Keywords
Chronic Kidney Disease, Nailfold Capillaroscopy, Microvascular Changes, Cross-Sectional Study, Renal Function, Disease Severity
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Jangid S, Madke B and Balwani M. A cross-sectional case-control study of nailfold capillaroscopy changes in patients with chronic kidney disease in tertiary care hospital in central India [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:322 (https://doi.org/10.12688/f1000research.147712.1)
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Study Protocol
A cross-sectional case-control study of nailfold capillaroscopy changes in patients with chronic kidney disease in tertiary care hospital in central India
[version 1; peer review: awaiting peer review]
PUBLISHED 23 Apr 2024
OPEN PEER REVIEW
REVIEWER STATUS
This article is included in the Datta Meghe Institute of Higher Education and Research collection.
Abstract
Corresponding author:
Shivani Jangid
Competing interests:
No competing interests were disclosed.
Grant information:
The author(s) declared that no grants were involved in supporting this work.
Copyright:
© 2024 Jangid S 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: Jangid S, Madke B and Balwani M. A cross-sectional case-control study of nailfold capillaroscopy changes in patients with chronic kidney disease in tertiary care hospital in central India [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:322 (https://doi.org/10.12688/f1000research.147712.1)
First published: 23 Apr 2024, 13:322 (https://doi.org/10.12688/f1000research.147712.1)
Latest published: 23 Apr 2024, 13:322 (https://doi.org/10.12688/f1000research.147712.1)
Introduction
Chronic Kidney Disease (CKD) is a global health concern with rising prevalence, affecting millions of individuals and posing a significant burden on healthcare systems worldwide.1 Nailfold capillaroscopy, a non-invasive imaging technique, has shown promise in providing insights into microvascular changes associated with various systemic diseases.2 However, its application in understanding the microvascular alterations in CKD remains an area that warrants further investigation.
Previous studies have demonstrated nailfold capillaroscopy’s utility in revealing microvascular abnormalities in conditions such as systemic sclerosis, Raynaud’s phenomenon, and autoimmune disorders.3,4 However, more literature is needed to explore the patterns and significance of nailfold capillary changes in CKD patients across different stages of the disease.
Understanding the microvascular changes in CKD is crucial, as it may offer insights into the pathophysiological mechanisms involved and potentially serve as a diagnostic or prognostic tool. Additionally, investigating the correlation between nailfold capillaroscopy changes and underlying etiologies in CKD patients could enhance our understanding of the disease’s heterogeneity.5
The proposed study aims to bridge this knowledge gap by conducting a comprehensive cross-sectional case-control analysis of nailfold capillaroscopy changes in CKD patients. By comparing findings with a control group, this research intends to elucidate potential correlations between microvascular alterations and the severity of CKD, contributing valuable information for clinical practice and future research endeavors.
Aim
To study the pattern of nailfold capillary changes via nailfold capillaroscopy in patients with CKD
Objectives
1. To determine the pattern of microvascular changes in nailfold capillaroscopy in patients with CKD (stage 1-5).
2. To identify the correlation of nailfold capillaroscopy changes with underlying etiology in patients with CKD.
3. To assess the correlation between nailfold capillaroscopy changes and renal function test parameters.
4. To evaluate the severity of CKD with the microvascular changes observed in CKD patients.
5. To compare the nailfold capillaroscopy of patients with CKD with patients without underlying renal disease.
Methods
Study design
This research will adopt a cross-sectional case-control study design to investigate the pattern of nailfold capillary changes in patients with chronic kidney disease (CKD). The cross-sectional design allows for simultaneously examining the exposure and outcome, providing a snapshot of the relationship between nailfold capillaroscopy changes and CKD in a defined population.
Study population: The study will include two groups of participants:
1. Case Group (CKD patients): Sixty (60) individuals diagnosed with chronic renal disease (stage 1-5), representing both genders and aged over 18 years, will be recruited from the Nephrology department at Shalinitai Meghe Super Specialty Hospital. Inclusion criteria for this group include a confirmed diagnosis of CKD and willingness to participate.
2. Control Group (Non-renal patients): Another sixty (60) individuals without any underlying renal disease, matching both genders and over 18 years, will be selected as the control group. They will be recruited from the Dermatology department at Acharya Vinoba Bhave Rural Hospital, Sawangi. Similar to the case group, participants in the control group must be willing to participate in the study.
Place of study: The study will be conducted in two healthcare facilities in Central India:
1. Shalinitai Meghe Super Specialty Hospital: This hospital will be the primary site for recruiting patients with chronic renal disease (CKD). The Nephrology department will facilitate the identification and enrollment of eligible CKD patients.
2. Acharya Vinoba Bhave Rural Hospital, Sawangi: This hospital will be the secondary site and will be used to recruit individuals without any underlying renal disease, serving as the control group. The Dermatology department will assist in the identification and recruitment of control participants.
Exclusion criteria
1) Damage to finger in recent times.
2) Chemicals that may affect the quality of investigation of fingers.
3) Patients having any autoimmune disease.
4) Patients have any underlying systemic disease known to affect digital microcirculation.
5) Patients with infective endocarditis and other systemic diseases like cardiac/hepatic disease, psoriasis, and lichen planus.
Enrollment process
1. Identification of potential participants: Patients diagnosed with chronic renal disease (stage 1-5) and those without any underlying renal disease will be identified from the Nephrology and Dermatology departments, respectively, at Shalinitai Meghe Super Specialty Hospital and Acharya Vinoba Bhave Rural Hospital.
2. Informed consent: Trained healthcare professionals will approach potential participants and provide detailed information about the study, including its purpose, procedures, potential risks, and benefits. This will be followed by obtaining written and signed informed consent from individuals willing to participate.
3. Screening for inclusion criteria: Participants will be screened to ensure they meet the inclusion criteria, including age, diagnosis of chronic renal disease, or absence of underlying renal disease. Those meeting the criteria will be eligible for enrollment.
4. Verification of exclusion criteria: A thorough check will be conducted to verify that potential participants do not meet any of the exclusion criteria, such as recent finger damage, exposure to chemicals affecting finger investigation, autoimmune diseases, underlying systemic diseases affecting digital microcirculation, or specific systemic diseases.
5. Cross-matching for age and gender: To minimize potential biases related to age and gender, participants in the case and control groups will be cross-matched for these demographic factors.
6. Institutional ethics committee approval: The study protocol, including the informed consent process, will be submitted for review and approval by the Institutional Ethics Committee at both participating hospitals. Enrollment will commence upon obtaining ethical approval.
7. Baseline data collection: Demographic information, clinical history, and relevant medical records, including diagnosis and duration of chronic renal disease, will be collected for each participant.
8. Nailfold capillaroscopy procedure: Patients will undergo nailfold capillaroscopy using DINOLITE AM4113ZT. Nail lacquer will be removed using acetone, and the procedure will be conducted in a controlled environment to ensure accurate and reliable results.6
9. Clinical parameters collection: Additional clinical parameters, such as renal function test results (serum creatinine, urea, electrolytes, calcium), imaging findings (USG KUB), and other relevant investigations, will be recorded.
10. Grading of chronic renal disease: Chronic renal disease will be graded according to the KDIGO 2012 classification.
11. MDAD approach for nailfold capillaroscopy analysis: The MDAD approach, incorporating qualitative and quantitative parameters (capillary morphology, diameter, architecture, and density), will be applied to analyze the nailfold capillaroscopy findings.
12. Statistical analysis: Collected data will be subjected to statistical analysis using appropriate tests (chi-square test, student t-test) with R Studio Version 4.3.1.
13. Ongoing monitoring and follow-up: Enrolled participants will be monitored throughout the study period. Any adverse events or changes in health status will be documented and addressed promptly.
14. Closure of enrollment: Enrollment will be concluded once the predetermined sample size is achieved, ensuring adequate participants in both the case and control groups.
Data collection process
The data collection process for this cross-sectional case-control study involves systematically gathering information from participants in both the case and control groups. Demographic details, such as age, gender, occupation, address, and marital status, will be recorded for all participants. The clinical history of individuals, including the duration of chronic renal disease, underlying etiology, and relevant comorbidities, will also be documented.
Confirmation of chronic renal disease (stage 1-5) diagnosis in the case group will be ensured through a thorough examination of medical records and diagnostic reports. Renal function tests, encompassing serum creatinine, serum urea, electrolytes (sodium and potassium), and serum calcium, will be conducted and their results recorded. Imaging findings, specifically ultrasonography of kidneys, ureters, and bladder (USG KUB), will be documented for participants in the case group.
Additional laboratory investigations, including a complete blood count (CBC) and liver function tests, will be performed, and the results will be collected. Urine routine and microscopy data will be documented for both case and control groups. Intact parathyroid hormone (iPTH) and serum ferritin levels will also be included in the data collection for the case group.
Nailfold capillaroscopy will be a crucial component of data collection involving DINOLITE AM4113ZT. Images will be captured in a non-polarizing mode with oil immersion, and the analysis will follow the MDAD approach, considering capillary morphology, diameter, architecture, and density.
The grading of chronic renal disease will be determined according to the KDIGO 2012 classification, utilizing the comprehensive data collected from clinical and laboratory assessments. Statistical parameters, such as p-values derived from the analysis using SPSS 27.0 and GraphPad Prism 7.0, will be recorded.
Quality control measures will be implemented throughout the data collection to ensure accuracy and reliability. Regular calibration of equipment and ongoing monitoring will contribute to maintaining procedural consistency. Data entry into a secure database will follow, emphasizing proper coding and unique identifiers to preserve participant confidentiality.
Ethical considerations, including participant privacy, confidentiality, and informed consent, will be consistently prioritized throughout the data collection process. Ongoing monitoring and followup assessments will be conducted to address any changes in health status or adverse events among enrolled participants, contributing to the overall integrity of the study.
Sample size
Daniel’s formula for sample size
Where Z α/2 is the level of significance at 5%, i.e., 95%
Confidence interval = 1.96
P = prevalence of chronic kidney disease
d = desired error of margin = 5% = 0.05
n = 60 patients in each group
Case: Sample size [n] = 60
Control: Sample size [n] = 60
Sample size of the study = 120
Statistical methods
In this cross-sectional case-control study, a range of statistical methods will be applied to analyze and interpret the data gathered from participants. These methods have been carefully selected to address the study’s objectives, which focus on understanding the patterns of nailfold capillaroscopy changes in patients across various stages of chronic kidney disease (CKD). Descriptive statistics will play a crucial role in summarizing key characteristics of the study population. Demographic details, clinical histories, and laboratory parameters will be presented using means, standard deviations, medians, and percentages, providing a comprehensive overview of the participants. The chi-square test will be employed to analyze categorical data, explicitly examining the prevalence of specific nailfold capillaroscopy changes in CKD patients compared to the control group. This test is instrumental in identifying significant associations between categorical variables.
The student t-test will compare continuous variables between the case (CKD) and control groups. This includes the evaluation of quantitative parameters derived from nailfold capillaroscopy, renal function tests, and other relevant laboratory investigations. Using methods like Pearson or Spearman correlation coefficients, correlation analysis will assess the strength and direction of relationships between nailfold capillaroscopy changes and renal function test parameters. This approach helps identify any linear or non-linear associations. Multivariate analysis involving regression models like logistic regression will be considered to explore complex relationships between multiple variables simultaneously. This allows for assessing the independent contribution of various factors to nailfold capillaroscopy changes in CKD patients.
A comparative analysis of nailfold capillaroscopy grading across different stages of CKD will be conducted using appropriate statistical methods. This may include using analysis of variance (ANOVA) or non-parametric equivalents to assess variations. Statistical analyses will be conducted using specialized software packages, particularly SPSS 27.0 and GraphPad Prism 7.0, which are known for their versatility in handling diverse statistical tests and data visualization. The significance level (alpha) for hypothesis testing is set at 0.05, with results having p-values less than 0.05 considered statistically significant.
Ethical considerations and consent
The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) has granted its approval to the study protocol (Reference number: DMIHER (DU)/IEC/2023/143. Date: 21-03-2023). Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study’s objectives.
Discussion
The proposed study aims to investigate the patterns of nailfold capillaroscopy changes in patients with CKD and explore potential correlations with disease severity and etiology. Using nailfold capillaroscopy in systemic diseases has been well-established.7 In the context of CKD, the microvascular changes observed through nailfold capillaroscopy may provide valuable insights into the disease’s pathophysiological mechanisms. Previous research has demonstrated the utility of this imaging technique in identifying microvascular abnormalities in other systemic conditions, contributing to the understanding of disease progression.8
Correlation analyses between nailfold capillaroscopy changes and renal function parameters could offer a novel perspective on the vascular manifestations associated with CKD. Studies have shown that microvascular alterations detected through capillaroscopy are closely linked to disease severity and progression in various systemic disorders.9,10 Understanding similar associations in CKD patients may have implications for prognostication and management strategies.
The comparison of nailfold capillaroscopy findings between CKD patients and a control group without renal disease is a key aspect of this study. Such a comparative analysis is essential for establishing the specificity of the observed changes to CKD and may contribute to the differential diagnosis of microvascular abnormalities in clinical practice.11 While this study holds promise in advancing our understanding of the microvascular changes associated with CKD, several limitations need consideration. The hospital-based nature of the study may limit the generalizability of the findings to the broader population. Additionally, the cross-sectional design allows for identifying associations but precludes the establishment of causation.
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how to cite this article
Jangid S, Madke B and Balwani M. A cross-sectional case-control study of nailfold capillaroscopy changes in patients with chronic kidney disease in tertiary care hospital in central India [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:322 (https://doi.org/10.12688/f1000research.147712.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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