Association of intradialytic hypertension and antihypertensive medication use in patients undergoing maintenance hemodialysis: a prospective observational study

Mariam Sherif; Seeba Zachariah; Rajaram Jagdale

doi:10.12688/f1000research.144153.1

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Research Article

Association of intradialytic hypertension and antihypertensive medication use in patients undergoing maintenance hemodialysis: a prospective observational study

[version 1; peer review: 1 approved with reservations, 1 not approved]

Mariam Sherif¹, Seeba Zachariah ¹, Rajaram Jagdale^2,3

PUBLISHED 14 Jun 2024

Author details Author details

¹ College of Pharmacy, Gulf Medical University, Al Jurf, Ajman, 4184, United Arab Emirates
² Department of Nephrology, Thumbay University Hospital, Al jurf, Ajman, 4184, United Arab Emirates
³ College of Medicine, Gulf Medical University, Al Jurf, Ajman, 4184, United Arab Emirates

Mariam Sherif
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Software, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Seeba Zachariah
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Software, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing

Rajaram Jagdale
Roles: Conceptualization, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background

In patients with end-stage kidney disease (ESKD) undergoing maintenance hemodialysis, intradialytic hypertension and intradialytic hypotension are the common complications. The study aimed to collect and assess intradialytic Blood Pressure (BP) complications and their association with different factors, including BP medication.

Methods

This was a prospective observational study, conducted at the hemodialysis center in a teaching hospital in the UAE, that provide a specialist’s care for the patients receiving ongoing hemodialysis. Patient demographics, medications used, lab data and the peridialytic BP (pre-, intra-, and post-) dialytic BP were collected for a period of 6 months. SPSS Version 29, Armonk, NY was used for statistical analysis. Pearson Chi-square test and Fischer’s Exact test were used to compare the association between categorical variables to intradialytic hypertension and hypotension.

Results

Blood pressure data was collected from 47 hemodialysis patients for a total of 2616 hemodialysis sessions during the 6 months study period. Beta-blockers (68%) and calcium channel blockers (66%) were the commonly used antihypertensive medications in the study population. Intradialytic hypertension events were diagnosed in 49 hemodialysis sessions and intradialytic hypotension was diagnosed in 23 hemodialysis sessions. On comparing the effect of antihypertensive medication to the occurrence of intradialytic BP complications, ARBs and alpha-1 blockers showed no association to intradialytic hypertension, but beta-blockers and calcium channel blockers use were associated with increased number of intradialytic hypertension events (p-value <0.05). On the other hand, antihypertensive medication use showed no association with intradialytic hypotension.

Conclusions

Patients using ARBs or alpha-1 blockers had higher intradialytic hypertension events. Beta-blocker and calcium channel users had lower intradialytic hypertension events. Antihypertensive use showed no association with intradialytic hypotension events.

Keywords

Hypertension, comorbidities, intradialytic hypertension, intradialytic hypotension, factors, dialysis patients

Corresponding author: Seeba Zachariah

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2024 Sherif M et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Sherif M, Zachariah S and Jagdale R. Association of intradialytic hypertension and antihypertensive medication use in patients undergoing maintenance hemodialysis: a prospective observational study [version 1; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2024, 13:634 (https://doi.org/10.12688/f1000research.144153.1) First published: 14 Jun 2024, 13:634 (https://doi.org/10.12688/f1000research.144153.1) Latest published: 06 Jan 2025, 13:634 (https://doi.org/10.12688/f1000research.144153.2)

Introduction

Although hypertension is prevalent in more than 80% of chronic maintenance hemodialysis patients, there is no consensus about the BP threshold, BP target, and the effect of BP reduction on cardiovascular outcomes. Hypertension in the hemodialysis population is multifactorial and is different from other patient populations.¹^–⁵ Patients undergoing hemodialysis may experience several complications in their treatment journey that affect their quality of life. Many patients have varying adherence to therapy and struggle to achieve optimal blood pressure outcomes.⁶^–¹⁰

Although the drug treatment is effective, the number of patients who achieved adequate BP control is limited. BP obtained in dialysis centers poorly represents the usual level of blood pressure in hemodialysis patients, which makes the management of hypertension particularly challenging. Intradialytic hypertension and hypotension were observed, which might be due to multiple factors. Despite proper estimation of fluid removal during hemodialysis, it has been noted that many patients experience intradialytic BP complications. Factors that affect BP control are a multitude.¹¹^–¹³

All classes of antihypertensive drugs, including diuretics, were used in the hemodialysis population. The most commonly prescribed was a calcium channel blocker. Antihypertensives of choice varied in patients undergoing hemodialysis compared to patients who were not (stage 1-4 CKD). The choice of antihypertensives varies due to multiple factors, and intradialytic complications associated with antihypertensives need more research in different settings.¹⁴^,¹⁵

Aim

This study was to find details of the influence of intradialytic BP complications due to antihypertensive medicines. The prediction of blood pressure and other outcomes in hemodialysis patients is an important area of research, especially the influence of antihypertensive medications in intradialytic complications. By better understanding the factors that contribute to these complications, clinicians can improve hemodialysis patient care and help them live longer, healthier lives. Thus, the aim of the study was to assess the association of intradialytic hyper or hypotension with the antihypertensive medication use.

Methods

Research design & setting

This prospective observational study was conducted in the hemodialysis unit of a 350 bedded tertiary care teaching hospital in the UAE. This unit is considered one of the largest hemodialysis units in the UAE in private sector hospitals. The hemodialysis unit was functioning under the supervision of a nephrologist. Patient information was mostly collected from electronic medical records and the physician’s register of patient’s medications. The data collection process began on November 1, 2022, and continued until the end of April 2023.

Study population

Among the 56 patients undergoing regular hemodialysis, 47 patients were included in the study after excluding those who started maintenance hemodialysis for less than 3 months. The study focused on individuals undergoing hemodialysis due to end-stage renal disease. These patients were closely observed and followed up over a period of six months as part of the study's enrolment and data collection process.

Participants for the study were selected based on rigorous inclusion and exclusion criteria. Patients who were included in this study were Individuals who underwent maintenance hemodialysis as a component of their daily or weekly management of end-stage kidney disease. Adults aged 18 to 85 years and diagnosed with chronic kidney failure/end-stage kidney disease.

Ethical concerns

Patient confidentiality was maintained, and consent was obtained from the patients for the study. Ethical approval for the study was granted by the institutional review board of Gulf Medical University. Approval for the study was before starting data collection (IRB approval date: 19 November 2020; Ref No. IRB/COP/STD/07/Nov-2020). The principles of the Declaration of Helsinki were used in this research.

Data collection

All data were collected from the electronic medical records and the dialysis register. Recording of blood pressure during the hemodialysis sessions was taken as ambulatory or home BP measurements were not feasible. For every patient, the nurse measured and recorded BP at the start of dialysis (Pre dialysis BP), BP during dialysis (measured every 30 minutes, using an automatic cuff attached to the HD machine, an average of 6-8 BP reading is taken by the researcher (intra dialytic BP) and BP after the dialysis session ends (post dialytic BP). Generally, each hemodialysis session was for 4 hours unless complications led to an early finish. Data collection continued for six months to identify the pattern of blood pressure, intradialytic hypertension, and intradialytic hypotension complications that occurred during each dialysis session.

Data analysis

Descriptive statistics was used to summarize the data. Pearson Chi-square test and Fischer’s Exact test were used to compare the association between categorical variables to intradialytic hypertension and hypotension. SPSS Version 29, Armonk, NY (https://www.ibm.com/support/pages/downloading-ibm-spss-statistics-29011) was used for statistical analysis.

Results

An overview of the sociodemographic and health status characteristics of the 47 study participants is given in Table 1.²⁵

Table 1. Patient demographics at baseline.

Characteristics	Mean (±SD) or n (%)
Age in years, Mean (±SD)	55 (±13)
Less than 60 years, n (%)	26 (55.3)
60 years or above, n (%)	21 (44.7%)
Gender
Male	35 (74.5%)
Female	12 (25.5%)
Ethnicity
Arab	21 (44.7%)
Non-Arab	26 (55.4%)
Marital status
Married	42 (89.4%)
Not married	5 (10.6%)
Employment status: Employed	27 (57.4%)
Health insurance active	40 (85.1%)
Smoking status:
Current smoker	1 (2.1%)
Ex-smoker	04 (8.5%)
Never smoker	42 (89.3%)
BMI in kg/m², Mean (±SD)	28.12 (±5.77)
Dialysis vintage in months, mean (±SD)	26.89 (16.74)
Number of dialysis sessions per week
Two times per week	18 (38%)
Three times per week	29 (62)
Comorbidities
Diabetes	27 (57.4)
Hypertension	40 (85.1)
Dyslipidemia	9 (19.1)
Cerebrovascular accident (CVA)	14 (29.8)
Ischemic heart disease	6 (12.8)
Anemia	27 (57.4)
Asthma	1 (2.1)
Depression	1 (2.1)
Obstructive sleep apnea (OSA)	1 (2.1)

Average institutional blood pressure recordings before, during, and after dialysis of the study population were provided in Table 2.

Table 2. Average peri-dialytic values of 6 months study period (n=47).

Blood pressure	Mean	(±SD)
Pre dialytic SBP (mmHg)	153.6	14.5
Pre dialytic DBP (mmHg)	82.1	9.3
Intra dialytic SBP (mmHg)	149.6	14.7
Intra dialytic DBP (mmHg)	81.2	7.1
Post dialytic SBP (mmHg)	149.2	17.1
Post dialytic DBP (mmHg)	81.0	7.6
Pre dialytic weight (kg)	77.2	16.8
Post dialytic weight (kg)	74.8	16.4
Ultrafiltration (L)	2.4	0.7

Calcium channel blockers and beta blockers were the commonly used antihypertensive medications. Six (13%) patients were not on any antihypertensive medication. A combination of four or more antihypertensives was used by 16 (34%) patients, indicating the presence of resistant hypertension (Figure 1). Systolic BP was elevated during most of the dialysis sessions while the diastolic BP were controlled in most sessions.

Figure 1. Antihypertensive use among the study population (n=47).

X-axis shows percentage of patients on antihypertensives, and Y-axis shows antihypertensive drug class.

A total of 2616 hemodialysis sessions occurred during the 6 months study period. Out of them, 49 (1.9%) sessions had intradialytic hypertension and 23 (0.9%) dialysis sessions had intradialytic hypotension. This include intradialytic hypertension in 16 (34%) patients and Intradialytic hypotension in 11(23%). Both events occurred in 3 (6%) patients. Twenty-three (49%) patients had no interdialytic BP complications.

Association between Antihypertensive Medication and Intradialytic hyper or hypotension was provided in Table 3, which is statistically significant for Angiotensin Receptor Blocker (ARB), Beta Blockers, Calcium Channel Blockers, and Alpha-1 Blockers.

Table 3. Association of antihypertensives to intradialytic Blood Pressure Complications.

Antihypertensive class	Antihypertensive use	No Intra-dialytic Hypertension	Intra-dialytic Hypertension	P-value^#
Angiotensin Receptor Blocker (ARB)	Nonuser	27 (57.4%)	9 (19.1%)	0.02*
Angiotensin Receptor Blocker (ARB)	User	4 (8.5%)	7 (14.9%)	0.02*
Beta Blockers	Nonuser	15 (31.9%)	2 (4.3%)	0.02*
Beta Blockers	User	16 (34.0%)	14 (29.8%)	0.02*
Calcium Channel Blockers	Nonuser	13 (27.7%)	1 (2.1%)	0.01*
Calcium Channel Blockers	User	18 (38.3%)	15 (31.9%)	0.01*
Alpha-1 Blockers	Nonuser	24 (51.1%)	7 (14.9%)	0.02*
Alpha-1 Blockers	User	7 (14.9%)	9 (19.1%)	0.02*
Diuretics	Nonuser	29 (61.7%)	16 (34.0%)	0.30
Diuretics	User	2 (4.3%)	0	0.30
Central acting agents	Nonuser	26 (55.3%)	10 (21.3%)	0.10
Central acting agents	User	5 (10.6%)	6 (12.8%)	0.10
Vasodilators	Nonuser	28 (59.6%)	13 (27.7%)	0.38
Vasodilators	User	3 (6.4%)	3 (6.4%)	0.38

* P value <0.05.

# Pearson Chi-Square test or Fischer exact test.

Patients using ARBs or alpha-1 blockers had higher intradialytic hypertension events. Beta-blocker and calcium channel users had lower intradialytic hypertension. Other antihypertensive use did not show any association with intradialytic hypertension. Antihypertensive medication use showed no association with intradialytic hypotension.

Discussion

The most common intradialytic complication in our study was intradialytic hypertension. Hemodialysis helps in managing hypertension in ESKD patients along with antihypertensive medications. The association of antihypertensive use with intradialytic BP complications was a unique finding in the region. Some of the antihypertensive medications were associated with more intradialytic hypertension than others. Thrice-weekly sessions were the most common approach for maintenance hemodialysis. Frequent dialysis sessions are crucial for effectively removing waste products and excess fluid from the body to maintain proper kidney function. Antihypertensive medications are essential for controlling blood pressure in dialysis patients, as hypertension is a common comorbidity in this population and is associated with increased cardiovascular risks. Effective fluid removal is critical to prevent complications associated with fluid overload, such as congestive heart failure and pulmonary edema in ESKD.¹⁶^,¹⁷

Beta-blockers were the most commonly prescribed cardiovascular medication among dialysis patients. Beta-blockers are well-known for their ability to lower heart rate and blood pressure, making them valuable in managing hypertension and reducing the workload on the heart. Additionally, they have been shown to be beneficial in improving overall cardiovascular outcomes and reducing mortality rates in patients with CKD and ESKD. The use of beta-blockers in this population aligns with current guidelines and represents a proactive approach to cardiovascular risk reduction. Beta-blockers calcium channel blockers (CCBs) were associated with more frequent intradialytic hypertension in our study population. CCBs are also effective in reducing blood pressure and have been shown to improve outcomes in CKD patients, particularly in terms of slowing the progression of kidney disease. CCBs are considered safe and well-tolerated in patients with impaired kidney function, making them a suitable choice for dialysis patients who often have pre-existing cardiovascular complications. Loop diuretics, such as furosemide, are crucial for managing fluid overload and congestive heart failure, common complications in dialysis patients due to impaired kidney function. These medications promote diuresis and help maintain fluid balance and hemodynamic stability in this vulnerable population.¹⁴^,¹⁸^,¹⁹

The low utilization of ACE inhibitors in this study may be attributed to individual patient characteristics, contraindications, or specific preferences of healthcare providers. Similarly, thiazide diuretics are often used as add-on therapy to manage hypertension in CKD patients. Thiazide diuretics are effective in promoting diuresis and blood pressure control, but their usage may be limited in patients with advanced kidney disease due to decreased renal excretion and potential electrolyte disturbances. Vasodilators, such as hydralazine and Nifedipine, were also relatively underutilized. Vasodilators act to relax blood vessels, thus reducing blood pressure and improving cardiac function. Their low usage in this study could be attributed to various factors, including the presence of alternative medications or individual patient responses.¹³^,¹⁵^,¹⁸^,²⁰

Hypertension is a significant concern among dialysis patients due to impaired kidney function and fluid balance. Our study observed that a substantial proportion of patients were prescribed antihypertensive medications. Beta-blockers, such as Bisoprolol, Carvedilol, Metoprolol, Nebivolol, and more. Intradialytic BP complications are reported in many studies, but not their association with antihypertensive medications, making our study unique. Intradialytic hypertension is a concern that needs to be addressed more effectively.²¹^–²⁴

Conclusion

Intradialytic hypertension was the most common BP complication among our study population (supported by literature), contrary to the common belief that intradialytic hypotension is the most common complication among patients undergoing hemodialysis. Beta-blockers and calcium channel blockers were the most prescribed antihypertensives in the study population. The study population showed more frequently elevated Systolic BP and elevated Diastolic BP were less frequent. Patients using ARBs or alpha-1 blockers had higher intradialytic hypertension events. Beta-blocker and calcium channel users had lower intradialytic hypertension events. On the other hand, antihypertensive medication use showed no association with intradialytic hypotension.

Strengths and limitations

The study was conducted in one of the biggest private healthcare settings in the United Arab Emirates. Most of the patients were on antihypertensive medications for their hypertension management. This study focused on assessing relationship of antihypertensive medication on intradialytic blood pressure complications and the study being conducted in a single site produces a cohort effect as all patients receive same standard of care during the study period.

Though number of study population was limited, it was enough to find statistically significant association. Medication adherence was not collected in detail in this study. Patients were asked about medication adherence and found they were generally adherent to their antihypertensive medications, as there were clinical pharmacy interventions prior to this study to improve medication adherence. Reinforcement advice was provided to the study participants on the importance of medication adherence.

Data availability

Figshare: BP in Hemodialysis patients.xlsx. https://doi.org/10.6084/m9.figshare.24417031.v2.²⁵

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

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Version 2

VERSION 2 PUBLISHED 14 Jun 2024

Author details Author details

Rajaram Jagdale
Roles: Conceptualization, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (2)

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Published: 06 Jan 2025, 13:634

https://doi.org/10.12688/f1000research.144153.2

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Published: 14 Jun 2024, 13:634

https://doi.org/10.12688/f1000research.144153.1

© 2024 Sherif M et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Sherif M, Zachariah S and Jagdale R. Association of intradialytic hypertension and antihypertensive medication use in patients undergoing maintenance hemodialysis: a prospective observational study [version 1; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2024, 13:634 (https://doi.org/10.12688/f1000research.144153.1)

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Open Peer Review

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PUBLISHED 14 Jun 2024

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Reviewer Report 01 Aug 2024

Peter K Uduagbamen, Bowen University / Bowen University Teaching Hospital, Ogbomosho, Nigeria

Approved with Reservations

https://doi.org/10.5256/f1000research.157907.r302267

Authors should mention specific timings for BP measurements. How were the necessary precautions in BP measurement effected?
What about the dialyzable and the non-dialyzable anti-hypertensive drugs and their effects.
Food taken within 30 minutes to an hour prior to dialysis and during dialysis could affect the intradialytic BP pattern, how was this taken care of?
A relationship between the hematocrit and the BP variation should also be given as lower values increases the risk of intradialytic hypotension.
Intradialytic hypotension commonly occur within the first 2 hours of dialysis while intradialytic hypertension common occur in the later part of dialysis, how was these fathom in the participants' preparation?
Again the gradient between pre and intra dialytic solute concentration also determine the intradialytic BP variations. So an assessment of the pre and post dialytic solute concentration would be very important.
Thiazides and diuretics particularly the thiazides are better drugs for managing systolic hypertension than other anti-hypertensives. It should have been kept in mind in participants preparation, data collection/analysis and finding a relationship between these drugs and cardiac output, end-diastolic volume and pressure, stroke volume and peripheral resistance.
These details are essential to strengthen this study.
Increase your references and cite recent studies on this topics. Intra dialytic blood pressure control appear more of a burden in Africa particularly sub-Sahara Africa, perhaps due to several prominent factors. Citing some authors from this region could only strengthen your study the more.
Please revise accordingly.

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Partly
Are sufficient details of methods and analysis provided to allow replication by others?

No
If applicable, is the statistical analysis and its interpretation appropriate?

Yes
Are all the source data underlying the results available to ensure full reproducibility?

No
Are the conclusions drawn adequately supported by the results?

No

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: nephrology, cardiology, metabolism, chemical pathology

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Author Response 06 Jan 2025

Seeba Zachariah, College of Pharmacy, Gulf Medical University, Al Jurf, 4184, United Arab Emirates

06 Jan 2025

Author Response

1. Authors should mention specific timings for BP measurements. How were the necessary precautions in BP measurement effected?
Author Response: The dialysis center was functioning from 7 AM to 11 AM ... Continue reading 1. Authors should mention specific timings for BP measurements. How were the necessary precautions in BP measurement effected?
Author Response: The dialysis center was functioning from 7 AM to 11 AM and was working in 3 different shifts (morning, noon and evening). Most of the dialysis sessions were for 4 hours. Patients came at their scheduled timing for the dialysis.
Pre dialytic BP was measured before the start of dialysis, after 5 min rest period. Intradialytic BP was measured every 30 minutes, using an automatic cuff attached to the hemodialysis machine. All these BP measurements and data entry to the patient medical were done by the well-trained nurses in the center. The researcher calculated the average of 6 BP recording as the intradialytic BP. Precautions were taken to minimize the BP measurement effect by using validated BP monitors, trained nursing staff and by calculating the average of 6 periodic intradialytic BP readings.

2. What about the dialyzable and the non-dialyzable anti-hypertensive drugs and their effects?
Author Response: Details about dialyzability of antihypertensives and their effects are added in the introduction and results.

3.Food taken within 30 minutes to an hour prior to dialysis and during dialysis could affect the intradialytic BP pattern, how was this taken care of?
Author Response: Food taken with in 1 hour prior to hemodialysis or during dialysis can increase the risk of hypotension by increasing splenic and hepatic blood flow to the abdominal viscera and significantly reduces the venous return. All patients were educated by the dialysis team regarding dialysis procedure and instructions.

4. A relationship between the hematocrit and the BP variation should also be given as lower values increases the risk of intradialytic hypotension.
Author Response: This study checked relationship between anemia and BP variation. Hematocrit data was not used.

5. Again the gradient between pre and intra dialytic solute concentration also determine the intradialytic BP variations. So an assessment of the pre and post dialytic solute concentration would be very important.
Author Response: Even though using a low-sodium dialysate could reduce intradialytic hypertension events, all patients were given the same standard dialysate at the study site.

6. Thiazides and diuretics particularly the thiazides are better drugs for managing systolic hypertension than other anti-hypertensives. It should have been kept in mind in participants preparation, data collection/analysis and finding a relationship between these drugs and cardiac output, end-diastolic volume and pressure, stroke volume and peripheral resistance.
Author Response: These details are essential to strengthen this study. Increase your references and cite recent studies on this topics.
Thiazide diuretics were not used among the study population.

7. Intra dialytic blood pressure control appear more of a burden in Africa particularly sub-Sahara Africa, perhaps due to several prominent factors. Citing some authors from this region could only strengthen your study the more. Please revise accordingly.
Author Response: 2 citations are replaced with better ones.
1. Authors should mention specific timings for BP measurements. How were the necessary precautions in BP measurement effected?
Author Response: The dialysis center was functioning from 7 AM to 11 AM and was working in 3 different shifts (morning, noon and evening). Most of the dialysis sessions were for 4 hours. Patients came at their scheduled timing for the dialysis.
Pre dialytic BP was measured before the start of dialysis, after 5 min rest period. Intradialytic BP was measured every 30 minutes, using an automatic cuff attached to the hemodialysis machine. All these BP measurements and data entry to the patient medical were done by the well-trained nurses in the center. The researcher calculated the average of 6 BP recording as the intradialytic BP. Precautions were taken to minimize the BP measurement effect by using validated BP monitors, trained nursing staff and by calculating the average of 6 periodic intradialytic BP readings.

2. What about the dialyzable and the non-dialyzable anti-hypertensive drugs and their effects?
Author Response: Details about dialyzability of antihypertensives and their effects are added in the introduction and results.

3.Food taken within 30 minutes to an hour prior to dialysis and during dialysis could affect the intradialytic BP pattern, how was this taken care of?
Author Response: Food taken with in 1 hour prior to hemodialysis or during dialysis can increase the risk of hypotension by increasing splenic and hepatic blood flow to the abdominal viscera and significantly reduces the venous return. All patients were educated by the dialysis team regarding dialysis procedure and instructions.

4. A relationship between the hematocrit and the BP variation should also be given as lower values increases the risk of intradialytic hypotension.
Author Response: This study checked relationship between anemia and BP variation. Hematocrit data was not used.

5. Again the gradient between pre and intra dialytic solute concentration also determine the intradialytic BP variations. So an assessment of the pre and post dialytic solute concentration would be very important.
Author Response: Even though using a low-sodium dialysate could reduce intradialytic hypertension events, all patients were given the same standard dialysate at the study site.

6. Thiazides and diuretics particularly the thiazides are better drugs for managing systolic hypertension than other anti-hypertensives. It should have been kept in mind in participants preparation, data collection/analysis and finding a relationship between these drugs and cardiac output, end-diastolic volume and pressure, stroke volume and peripheral resistance.
Author Response: These details are essential to strengthen this study. Increase your references and cite recent studies on this topics.
Thiazide diuretics were not used among the study population.

7. Intra dialytic blood pressure control appear more of a burden in Africa particularly sub-Sahara Africa, perhaps due to several prominent factors. Citing some authors from this region could only strengthen your study the more. Please revise accordingly.
Author Response: 2 citations are replaced with better ones.
Competing Interests: No competing interests were disclosed. Close
Report a concern
Respond or Comment

COMMENTS ON THIS REPORT

Author Response 06 Jan 2025

Seeba Zachariah, College of Pharmacy, Gulf Medical University, Al Jurf, 4184, United Arab Emirates

06 Jan 2025

Author Response

1. Authors should mention specific timings for BP measurements. How were the necessary precautions in BP measurement effected?
Author Response: The dialysis center was functioning from 7 AM to 11 AM ... Continue reading 1. Authors should mention specific timings for BP measurements. How were the necessary precautions in BP measurement effected?
Author Response: The dialysis center was functioning from 7 AM to 11 AM and was working in 3 different shifts (morning, noon and evening). Most of the dialysis sessions were for 4 hours. Patients came at their scheduled timing for the dialysis.
Pre dialytic BP was measured before the start of dialysis, after 5 min rest period. Intradialytic BP was measured every 30 minutes, using an automatic cuff attached to the hemodialysis machine. All these BP measurements and data entry to the patient medical were done by the well-trained nurses in the center. The researcher calculated the average of 6 BP recording as the intradialytic BP. Precautions were taken to minimize the BP measurement effect by using validated BP monitors, trained nursing staff and by calculating the average of 6 periodic intradialytic BP readings.

2. What about the dialyzable and the non-dialyzable anti-hypertensive drugs and their effects?
Author Response: Details about dialyzability of antihypertensives and their effects are added in the introduction and results.

3.Food taken within 30 minutes to an hour prior to dialysis and during dialysis could affect the intradialytic BP pattern, how was this taken care of?
Author Response: Food taken with in 1 hour prior to hemodialysis or during dialysis can increase the risk of hypotension by increasing splenic and hepatic blood flow to the abdominal viscera and significantly reduces the venous return. All patients were educated by the dialysis team regarding dialysis procedure and instructions.

4. A relationship between the hematocrit and the BP variation should also be given as lower values increases the risk of intradialytic hypotension.
Author Response: This study checked relationship between anemia and BP variation. Hematocrit data was not used.

5. Again the gradient between pre and intra dialytic solute concentration also determine the intradialytic BP variations. So an assessment of the pre and post dialytic solute concentration would be very important.
Author Response: Even though using a low-sodium dialysate could reduce intradialytic hypertension events, all patients were given the same standard dialysate at the study site.

6. Thiazides and diuretics particularly the thiazides are better drugs for managing systolic hypertension than other anti-hypertensives. It should have been kept in mind in participants preparation, data collection/analysis and finding a relationship between these drugs and cardiac output, end-diastolic volume and pressure, stroke volume and peripheral resistance.
Author Response: These details are essential to strengthen this study. Increase your references and cite recent studies on this topics.
Thiazide diuretics were not used among the study population.

7. Intra dialytic blood pressure control appear more of a burden in Africa particularly sub-Sahara Africa, perhaps due to several prominent factors. Citing some authors from this region could only strengthen your study the more. Please revise accordingly.
Author Response: 2 citations are replaced with better ones.
1. Authors should mention specific timings for BP measurements. How were the necessary precautions in BP measurement effected?
Author Response: The dialysis center was functioning from 7 AM to 11 AM and was working in 3 different shifts (morning, noon and evening). Most of the dialysis sessions were for 4 hours. Patients came at their scheduled timing for the dialysis.
Pre dialytic BP was measured before the start of dialysis, after 5 min rest period. Intradialytic BP was measured every 30 minutes, using an automatic cuff attached to the hemodialysis machine. All these BP measurements and data entry to the patient medical were done by the well-trained nurses in the center. The researcher calculated the average of 6 BP recording as the intradialytic BP. Precautions were taken to minimize the BP measurement effect by using validated BP monitors, trained nursing staff and by calculating the average of 6 periodic intradialytic BP readings.

2. What about the dialyzable and the non-dialyzable anti-hypertensive drugs and their effects?
Author Response: Details about dialyzability of antihypertensives and their effects are added in the introduction and results.

3.Food taken within 30 minutes to an hour prior to dialysis and during dialysis could affect the intradialytic BP pattern, how was this taken care of?
Author Response: Food taken with in 1 hour prior to hemodialysis or during dialysis can increase the risk of hypotension by increasing splenic and hepatic blood flow to the abdominal viscera and significantly reduces the venous return. All patients were educated by the dialysis team regarding dialysis procedure and instructions.

4. A relationship between the hematocrit and the BP variation should also be given as lower values increases the risk of intradialytic hypotension.
Author Response: This study checked relationship between anemia and BP variation. Hematocrit data was not used.

5. Again the gradient between pre and intra dialytic solute concentration also determine the intradialytic BP variations. So an assessment of the pre and post dialytic solute concentration would be very important.
Author Response: Even though using a low-sodium dialysate could reduce intradialytic hypertension events, all patients were given the same standard dialysate at the study site.

6. Thiazides and diuretics particularly the thiazides are better drugs for managing systolic hypertension than other anti-hypertensives. It should have been kept in mind in participants preparation, data collection/analysis and finding a relationship between these drugs and cardiac output, end-diastolic volume and pressure, stroke volume and peripheral resistance.
Author Response: These details are essential to strengthen this study. Increase your references and cite recent studies on this topics.
Thiazide diuretics were not used among the study population.

7. Intra dialytic blood pressure control appear more of a burden in Africa particularly sub-Sahara Africa, perhaps due to several prominent factors. Citing some authors from this region could only strengthen your study the more. Please revise accordingly.
Author Response: 2 citations are replaced with better ones.
Competing Interests: No competing interests were disclosed. Close
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Reviewer Report 23 Jul 2024

Carmine Zoccali, Renal Research Institute, New York, New York, USA; Institute of Molecular Biology and Genetics (Biogem), Ariano Irpino, Italy; Associazione Ipertensione Nefrologia Trapianto Renale (IPNET), Reggio Calabria, Italy

Not Approved

https://doi.org/10.5256/f1000research.157907.r302273

The study aimed to assess intradialytic blood pressure (BP) complications and their association with various factors, including BP medication, in patients with end-stage kidney disease (ESKD) undergoing maintenance hemodialysis. It was a prospective observational study conducted at a hemodialysis center ... Continue reading

Small Sample Size: The study involved only 47 patients, which is a relatively small sample size. This limits the generalizability of the findings and increases the risk of type II errors.
Confounding Factors: The study is observational and thus inherently susceptible to confounding factors. The association between antihypertensive medications and intradialytic BP complications may be influenced by unmeasured variables such as patient comorbidities, dialysis parameters, and adherence to medication.
Contradictory Findings: The study's findings contrast with existing evidence from randomized clinical trials. For instance, small randomized trials have shown that amlodipine is well-tolerated and does not increase the risk of intradialytic hypotension, while beta-blockers are known to worsen hemodynamic tolerance to dialysis (Haddiya I, Valoti S: Current Knowledge of Beta-Blockers in Chronic Hemodialysis Patients. Int J Nephrol Renovasc Dis [Internet] Volume 16: 223–230, 2023).
Lack of Randomization: Without randomization, it is difficult to establish causality. The associations observed may not reflect true causal relationships.
Short Study Duration: The 6-month duration may not be sufficient to capture long-term trends and outcomes related to intradialytic BP complications.

While the study impacts a relevant clinical question, its small sample size and susceptibility to confounding limit the robustness of the conclusions. The findings contrast with existing evidence, particularly regarding the effects of beta-blockers and calcium channel blockers on hemodynamic tolerance during dialysis.

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

No
Are sufficient details of methods and analysis provided to allow replication by others?

Yes
If applicable, is the statistical analysis and its interpretation appropriate?

No
Are all the source data underlying the results available to ensure full reproducibility?

No
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: hemodialysis, cardiovascular disease

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

CITE

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Author Response 24 Jul 2024

Seeba Zachariah, College of Pharmacy, Gulf Medical University, Al Jurf, 4184, United Arab Emirates

24 Jul 2024

Author Response

Philosophical underpinning of this research is real-world observational, but the reviewer comments are from an experimental interventional research viewpoint. The mix up of research paradigms creates confusion. Causal relationship is ... Continue reading Philosophical underpinning of this research is real-world observational, but the reviewer comments are from an experimental interventional research viewpoint. The mix up of research paradigms creates confusion. Causal relationship is not a goal of our research, the research is to explore association of certain variables. As the study is a population-based no sampling was performed, no sample size was calculated, all eligible patient data were included. The findings are not for generalizing, but to encourage future research. Patient data for 6 months on BP having a few thousands of measurements provides a robust exploratory assessment, which is statistically valid. Confounding factors were also mentioned ignoring real-world research philosophy. All real-world research accommodates all factors that contribute and do not try to control the variables as in clinical trials. Even pragmatic clinical trials and intention-to-treat analysis are adopting real-world research philosophy elements. It is unfortunate compare all other research to per-protocol analysis type research strategy. Why not this real-world evidence contradicts to a ‘small’ clinical trial. The evidence generated from real-world research and clinical trial are to be interpreted differently or not. Duration of research is fair enough to explore association, may not be enough for finding causal relationship which is not an aim of this research.
Philosophical underpinning of this research is real-world observational, but the reviewer comments are from an experimental interventional research viewpoint. The mix up of research paradigms creates confusion. Causal relationship is not a goal of our research, the research is to explore association of certain variables. As the study is a population-based no sampling was performed, no sample size was calculated, all eligible patient data were included. The findings are not for generalizing, but to encourage future research. Patient data for 6 months on BP having a few thousands of measurements provides a robust exploratory assessment, which is statistically valid. Confounding factors were also mentioned ignoring real-world research philosophy. All real-world research accommodates all factors that contribute and do not try to control the variables as in clinical trials. Even pragmatic clinical trials and intention-to-treat analysis are adopting real-world research philosophy elements. It is unfortunate compare all other research to per-protocol analysis type research strategy. Why not this real-world evidence contradicts to a ‘small’ clinical trial. The evidence generated from real-world research and clinical trial are to be interpreted differently or not. Duration of research is fair enough to explore association, may not be enough for finding causal relationship which is not an aim of this research.
Competing Interests: No competing interests were disclosed. Close
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COMMENTS ON THIS REPORT

Author Response 24 Jul 2024

Seeba Zachariah, College of Pharmacy, Gulf Medical University, Al Jurf, 4184, United Arab Emirates

24 Jul 2024

Author Response

Philosophical underpinning of this research is real-world observational, but the reviewer comments are from an experimental interventional research viewpoint. The mix up of research paradigms creates confusion. Causal relationship is ... Continue reading Philosophical underpinning of this research is real-world observational, but the reviewer comments are from an experimental interventional research viewpoint. The mix up of research paradigms creates confusion. Causal relationship is not a goal of our research, the research is to explore association of certain variables. As the study is a population-based no sampling was performed, no sample size was calculated, all eligible patient data were included. The findings are not for generalizing, but to encourage future research. Patient data for 6 months on BP having a few thousands of measurements provides a robust exploratory assessment, which is statistically valid. Confounding factors were also mentioned ignoring real-world research philosophy. All real-world research accommodates all factors that contribute and do not try to control the variables as in clinical trials. Even pragmatic clinical trials and intention-to-treat analysis are adopting real-world research philosophy elements. It is unfortunate compare all other research to per-protocol analysis type research strategy. Why not this real-world evidence contradicts to a ‘small’ clinical trial. The evidence generated from real-world research and clinical trial are to be interpreted differently or not. Duration of research is fair enough to explore association, may not be enough for finding causal relationship which is not an aim of this research.
Philosophical underpinning of this research is real-world observational, but the reviewer comments are from an experimental interventional research viewpoint. The mix up of research paradigms creates confusion. Causal relationship is not a goal of our research, the research is to explore association of certain variables. As the study is a population-based no sampling was performed, no sample size was calculated, all eligible patient data were included. The findings are not for generalizing, but to encourage future research. Patient data for 6 months on BP having a few thousands of measurements provides a robust exploratory assessment, which is statistically valid. Confounding factors were also mentioned ignoring real-world research philosophy. All real-world research accommodates all factors that contribute and do not try to control the variables as in clinical trials. Even pragmatic clinical trials and intention-to-treat analysis are adopting real-world research philosophy elements. It is unfortunate compare all other research to per-protocol analysis type research strategy. Why not this real-world evidence contradicts to a ‘small’ clinical trial. The evidence generated from real-world research and clinical trial are to be interpreted differently or not. Duration of research is fair enough to explore association, may not be enough for finding causal relationship which is not an aim of this research.
Competing Interests: No competing interests were disclosed. Close
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Version 2

VERSION 2 PUBLISHED 14 Jun 2024

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Version 2 (revision) 06 Jan 25
Version 1 14 Jun 24	read	read

Carmine Zoccali, Renal Research Institute, New York, USA; Institute of Molecular Biology and Genetics (Biogem), Ariano Irpino, Italy; Associazione Ipertensione Nefrologia Trapianto Renale (IPNET), Reggio Calabria, Italy
Peter K Uduagbamen, Bowen University / Bowen University Teaching Hospital, Ogbomosho, Nigeria

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10 Views

01 Aug 2024 | for Version 1

Peter K Uduagbamen, Bowen University / Bowen University Teaching Hospital, Ogbomosho, Nigeria

10 Views Cite this report Responses(1)

Approved With Reservations

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Partly
Are sufficient details of methods and analysis provided to allow replication by others?

No
If applicable, is the statistical analysis and its interpretation appropriate?

Yes
Are all the source data underlying the results available to ensure full reproducibility?

No
Are the conclusions drawn adequately supported by the results?

No

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

nephrology, cardiology, metabolism, chemical pathology

Respond to this report

Responses (1)

Author Response

06 Jan 2025

Seeba Zachariah, College of Pharmacy, Gulf Medical University, Al Jurf, 4184, United Arab Emirates

1. Authors should mention specific timings for BP measurements. How were the necessary precautions in BP measurement effected?
Author Response: The dialysis center was functioning from 7 AM to 11 AM and was working in 3 different shifts (morning, noon and evening). Most of the dialysis sessions were for 4 hours. Patients came at their scheduled timing for the dialysis.
Pre dialytic BP was measured before the start of dialysis, after 5 min rest period. Intradialytic BP was measured every 30 minutes, using an automatic cuff attached to the hemodialysis machine. All these BP measurements and data entry to the patient medical were done by the well-trained nurses in the center. The researcher calculated the average of 6 BP recording as the intradialytic BP. Precautions were taken to minimize the BP measurement effect by using validated BP monitors, trained nursing staff and by calculating the average of 6 periodic intradialytic BP readings.

2. What about the dialyzable and the non-dialyzable anti-hypertensive drugs and their effects?
Author Response: Details about dialyzability of antihypertensives and their effects are added in the introduction and results.

3.Food taken within 30 minutes to an hour prior to dialysis and during dialysis could affect the intradialytic BP pattern, how was this taken care of?
Author Response: Food taken with in 1 hour prior to hemodialysis or during dialysis can increase the risk of hypotension by increasing splenic and hepatic blood flow to the abdominal viscera and significantly reduces the venous return. All patients were educated by the dialysis team regarding dialysis procedure and instructions.

4. A relationship between the hematocrit and the BP variation should also be given as lower values increases the risk of intradialytic hypotension.
Author Response: This study checked relationship between anemia and BP variation. Hematocrit data was not used.

5. Again the gradient between pre and intra dialytic solute concentration also determine the intradialytic BP variations. So an assessment of the pre and post dialytic solute concentration would be very important.
Author Response: Even though using a low-sodium dialysate could reduce intradialytic hypertension events, all patients were given the same standard dialysate at the study site.

6. Thiazides and diuretics particularly the thiazides are better drugs for managing systolic hypertension than other anti-hypertensives. It should have been kept in mind in participants preparation, data collection/analysis and finding a relationship between these drugs and cardiac output, end-diastolic volume and pressure, stroke volume and peripheral resistance.
Author Response: These details are essential to strengthen this study. Increase your references and cite recent studies on this topics.
Thiazide diuretics were not used among the study population.

7. Intra dialytic blood pressure control appear more of a burden in Africa particularly sub-Sahara Africa, perhaps due to several prominent factors. Citing some authors from this region could only strengthen your study the more. Please revise accordingly.
Author Response: 2 citations are replaced with better ones.

View more View less

Competing Interests

No competing interests were disclosed.

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9 Views

23 Jul 2024 | for Version 1

9 Views Cite this report Responses(1)

Not Approved

Small Sample Size: The study involved only 47 patients, which is a relatively small sample size. This limits the generalizability of the findings and increases the risk of type II errors.
Confounding Factors: The study is observational and thus inherently susceptible to confounding factors. The association between antihypertensive medications and intradialytic BP complications may be influenced by unmeasured variables such as patient comorbidities, dialysis parameters, and adherence to medication.
Contradictory Findings: The study's findings contrast with existing evidence from randomized clinical trials. For instance, small randomized trials have shown that amlodipine is well-tolerated and does not increase the risk of intradialytic hypotension, while beta-blockers are known to worsen hemodynamic tolerance to dialysis (Haddiya I, Valoti S: Current Knowledge of Beta-Blockers in Chronic Hemodialysis Patients. Int J Nephrol Renovasc Dis [Internet] Volume 16: 223–230, 2023).
Lack of Randomization: Without randomization, it is difficult to establish causality. The associations observed may not reflect true causal relationships.
Short Study Duration: The 6-month duration may not be sufficient to capture long-term trends and outcomes related to intradialytic BP complications.

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

No
Are sufficient details of methods and analysis provided to allow replication by others?

Yes
If applicable, is the statistical analysis and its interpretation appropriate?

No
Are all the source data underlying the results available to ensure full reproducibility?

No
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

hemodialysis, cardiovascular disease

Respond to this report

Responses (1)

Author Response

24 Jul 2024

Seeba Zachariah, College of Pharmacy, Gulf Medical University, Al Jurf, 4184, United Arab Emirates

Philosophical underpinning of this research is real-world observational, but the reviewer comments are from an experimental interventional research viewpoint. The mix up of research paradigms creates confusion. Causal relationship is not a goal of our research, the research is to explore association of certain variables. As the study is a population-based no sampling was performed, no sample size was calculated, all eligible patient data were included. The findings are not for generalizing, but to encourage future research. Patient data for 6 months on BP having a few thousands of measurements provides a robust exploratory assessment, which is statistically valid. Confounding factors were also mentioned ignoring real-world research philosophy. All real-world research accommodates all factors that contribute and do not try to control the variables as in clinical trials. Even pragmatic clinical trials and intention-to-treat analysis are adopting real-world research philosophy elements. It is unfortunate compare all other research to per-protocol analysis type research strategy. Why not this real-world evidence contradicts to a ‘small’ clinical trial. The evidence generated from real-world research and clinical trial are to be interpreted differently or not. Duration of research is fair enough to explore association, may not be enough for finding causal relationship which is not an aim of this research.

View more View less

Competing Interests

No competing interests were disclosed.

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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[2] 2. Thurlow JS, Joshi M, Yan G, et al.: Global Epidemiology of End-Stage Kidney Disease and Disparities in Kidney Replacement Therapy. Am. J. Nephrol. 2021; 52(2): 98–107. PubMed Abstract | Publisher Full Text | Free Full Text

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Association of intradialytic hypertension and antihypertensive medication use in patients undergoing maintenance hemodialysis: a prospective observational study

Abstract

Background

Methods

Results

Conclusions

Keywords

Introduction

Aim

Methods

Research design & setting

Study population

Ethical concerns

Data collection

Data analysis

Results

Table 1. Patient demographics at baseline.

Table 2. Average peri-dialytic values of 6 months study period (n=47).

Figure 1. Antihypertensive use among the study population (n=47).

Table 3. Association of antihypertensives to intradialytic Blood Pressure Complications.

Discussion

Conclusion

Strengths and limitations

Data availability

References

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