AIMS AND OBJECTIVES 1. To measure serum levels of Nutritional and Inflammatory biomarkers in COVID-19 patients with Chronic Kidney Disease. 2. To evaluate the association between nutritional and inflammatory biomarkers in COVID-19 patients with Chronic Kidney Disease. STUDY DESIGN: It will be a hospital based prospective, cross-sectional study. PLACE OF STUDY: This study will be carried out in the Department of Biochemistry in association with the Department of Medicine, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi. STUDY DURATION: Study will be done over a period of 9 months. SELECTION OF SUBJECTS: Study Population: All admitted patients of Chronic KidneyDisease more than 18 years of age, in Lok Nayak Hospital, New Delhi who are rRT-PCR COVID-19 positive. INCLUSION CRITERIA: All known cases of Chronic Kidney Disease more than 18 years of age, who have recently been diagnosed as COVID-19 positive by rRT-PCR. OUTCOME VARIABLES PRIMARY OUTCOME: Association between nutritional and inflammatory biomarkers in COVID-19 patients with Chronic Kidney Disease. SECONDARY OUTCOME: Effect of severity of COVID-19 on nutritional and inflammatory biomarkers in COVID-19 patients with Chronic Kidney Disease. SAMPLE SIZE: After scanning the literature, to the best of our knowledge, no study on the association between nutritional and inflammatory biomarkers in COVID-19 patients with Chronic Kidney Disease could be found, thus making this an exploratory study. Sample size of convenience will be taken as described below:
100 admitted cases of Chronic Kidney Disease who have recently been diagnosed as COVID-19 positive by rRT-PCR. CONSENT: Written informed consent will be taken from all the subjects enrolled in the study. DETAILS OF LAB PROCEDURES: SAMPLE COLLECTION: Peripheral venous blood samples (5ml) will be collected in plain vial from all subjects by venipuncture after informed consent on the day of admission prior to initiation of any treatment. PROCESSING AND ANALYSIS OF SAMPLES: Samples in the plain vial will be centrifuged for 15 minutes at 1000 rpm×g. Collected serum will be stored at -800C to be used for measurement of :- • Nutritional biomarkers : Total Protein, Albumin, Prealbumin, Retinol Binding Protein, Vitamin D, Ascorbic acid, Folate, Vitamin B12, TSH, fT4, Calcium, Phosphate, Zinc, Cholesterol • Inflammatory biomarkers : hsCRP, IL-6, Ferritin, Albumin, Prealbumin, Retinol Binding Protein. • Routine biochemistry parameters. DATA COLLECTION: QUANTIFICATION OF ANALYTES: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ELISA (Enzyme Linked Immuno-sorbent Assay) | | | | | | ECLIA (Enhanced Chemiluminescence/ Electrochemiluminescence Based immunoassay) | | | | | | | | | | | | | | | | |
STATISTICAL ANALYSIS: All statistical analysis will be performed using SPSS 25 software. Kolmogorov–Smirnov test or Shapiro–Wilk test will be used to define the data as parametric or non-parametric. If data is found to be parametric, variables will be presented as mean and standard deviation for quantitative data. Comparison will be done by using one-way ANOVA followed by Tukey’s HSD test. Correlation analysis will be done by using Pearson’s correlation coefficient if data shows normal distribution (Parametric). If data is found to be non-parametric, variable will be presented as median and inter quartile range. Comparison will be done by using Kruskal Wallis test followed by Dunn test. Correlation analysis will be done by using Spearman correlation coefficient if data shows non-normal distribution (Non-parametric). p value <0.05 will be considered significant for all statistical analysis ETHICAL CONSIDERATION: 1.Study will be conducted after approval from the Institutional Ethics Committee. 2.The objectives and procedures of the study will be explained to all the respondents. 3.Patient information sheet will be given to all the respondents, participating in the study. 4.Informed consent will be taken from all the respondents. 5.​The data collected will be used for the study purpose only. ​ 6.​The option to opt out of the study will be kept open without any clause. 7.Complete confidentiality regarding the patient information would be maintained through all stages of study.
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