[version 1; peer review: awaiting peer review]
No competing interests were disclosed.
Chronic Kidney Disease (CKD) poses a significant global health burden, necessitating a deeper understanding of its microvascular manifestations. Nailfold capillaroscopy has emerged as a valuable tool in elucidating microvascular changes in various systemic conditions, yet its application in CKD remains underexplored. This study aims to investigate the patterns of nailfold capillaroscopy changes in CKD patients across different stages and explore potential correlations with disease severity and etiology.
A cross-sectional case-control study will be conducted, enrolling 120 CKD patients (stage 1-5) and 60 controls without renal disease. Nailfold capillaroscopy will be performed using DINOLITE AM4113ZT, and microvascular changes will be analyzed through the MDAD approach. Demographic details, clinical histories, renal function tests, imaging findings, and additional relevant parameters will be collected. Statistical analysis, including chi-square tests, student t-tests, and correlation analyses, will be conducted using SPSS 27.0 and GraphPad Prism 7.0.
It is anticipated that nailfold capillaroscopy will reveal distinct microvascular changes in CKD patients compared to the control group. Correlation analyses with renal function parameters may unveil microvascular alterations and disease severity associations. The study’s findings hold the potential to enhance diagnostic and prognostic strategies in CKD, providing valuable insights into the vascular aspects of the disease and contributing to the broader understanding of microvascular changes in systemic conditions.
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.
Previous studies have demonstrated nailfold capillaroscopy’s utility in revealing microvascular abnormalities in conditions such as systemic sclerosis, Raynaud’s phenomenon, and autoimmune disorders.
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.
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.
To study the pattern of nailfold capillary changes via nailfold capillaroscopy in patients with CKD
To determine the pattern of microvascular changes in nailfold capillaroscopy in patients with CKD (stage 1-5). To identify the correlation of nailfold capillaroscopy changes with underlying etiology in patients with CKD. To assess the correlation between nailfold capillaroscopy changes and renal function test parameters. To evaluate the severity of CKD with the microvascular changes observed in CKD patients. To compare the nailfold capillaroscopy of patients with CKD with patients without underlying renal disease.
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.
Patients diagnosed with chronic renal disease (stage 1-5) more than 18 years, irrespective of sex. A control group of patients without underlying renal disease for more than 18 years, irrespective of sex. Patients willing to participate.
Damage to finger in recent times. Chemicals that may affect the quality of investigation of fingers. Patients having any autoimmune disease. Patients have any underlying systemic disease known to affect digital microcirculation. Patients with infective endocarditis and other systemic diseases like cardiac/hepatic disease, psoriasis, and lichen planus.
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.
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
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.
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.
After the completion of the study, we will publish it in an indexed journal or conference.
The study has not yet started. After the publication of the protocol, we will start recruitment in the study.
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.
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.
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.
No data are associated with this article.