A COHORT STUDY ON THE BURDEN, DEMOGRAPHY, CLINICAL FEATURES AND SPECTRUM OF CHRONIC KIDNEY DISEASE IN THE RURAL AGRARIAN POPULATION OF INDIA WITH EMPHASIS ON CKDu.

 

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A COHORT STUDY ON THE BURDEN, DEMOGRAPHY, CLINICAL FEATURES AND SPECTRUM OF CHRONIC KIDNEY DISEASE IN THE RURAL AGRARIAN POPULATION OF INDIA WITH EMPHASIS ON CKDu.

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Joseph
Johny
Suceena Alexander suceena@gmail.com Christian Medical College Nephrology Vellore India -
Joseph Johny josephjohny1857@gmail.com Christian Medical College Nephrology Vellore India *
Prasanna Samuel prasanna.samuel@cmcvellore.ac.in Christian Medical College Nephrology Vellore India -
Anu Oommen anuoommen@cmcvellore.ac.in Christian Medical College Nephrology Vellore India -
 
 
 
 
 
 
 
 
 
 
 

The ‘Global Burden of Disease’ study has CKD as a major public health issue, with a worldwide prevalence of 11-13% and with significant morbidity and mortality. In recent decades, increased life expectancy and an increase in non-communicable diseases such as diabetes mellitus (DM), hypertension and obesity have led to a surge in CKD and end-stage kidney disease (ESKD) and a shift from infections to non-communicable diseases (NCD) in countries like India. A few large-scale studies on CKD/CKD(u) have been undertaken in known hot spots, but do not involve comparison between diverse agrarian and regional communities across India. Further, the data is skewed as the majority of the patients included in the studies are from urban areas. There is also a dearth of standardized epidemiological methods for data collection and comparison across regions.

Primary Objective: To understand the community burden of CKD/CKD(u) across diverse agrarian communities.

Secondary Objectives: 1. To identify the hot spots of CKD(u) defined as > 8% prevalence of CKDu in the agrarian communities across India.  2. To facilitate early detection and understand the demography, spectrum, and clinical features of CKD/CKD(u) across diverse agrarian communities.

Inclusion criteria for screening: 1. All adults between 18 to 45 years within the sampling frame 2. Written informed consent 3. Residential for at least 5 years.

Exclusion criteria for screening: Pregnant women. 

Case definitions: CKD case is defined as either s. creatinine >1.2mg/dL for females and >1.5mg/dL for males and/ or urine protein ≤2+ and/ or hematuria ≤1+ at baseline AND at three months. CKDu case is defined as s. creatinine >1.2mg/dL for females and >1.5mg/dL for males and urine protein ≤2+ and hematuria ≤1+ at baseline AND at three months WITHOUT any known secondary causes.

Outcome measures:

CKD cases- Prevalence of CKD at three months in adults aged 18-45 years.

CKDu cases- Prevalence of CKDu at three months in adults aged 18-45 years.

Qualitative outcome measures: To establish a framework within the selected hospitals for community surveillance of CKD.

Estimation Methods:  S. creatinine was estimated by the modified Jaffe method reported in mg/dL, and it was traceable to IDMS standards. The estimated glomerular filtration rate (eGFR) was calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Urine protein and hematuria were measured using a urine dipstick. Random blood sugar estimation was done by the catalyst method.

We used the DEGREE (Disadvantaged Populations estimated Glomerular Filtration Rate (eGFR) Epidemiology Study) protocol for population data collection and interpretation of renal functions at the baseline while recruiting all eligible subjects.

This trial is funded by CMC Vellore Mission Network Collaborative grant [IRB Min No. 15577 dated 26.07.2023] of the PI [SA]. 

There were three different agrarian communities in three different states in India, namely Odisha, Uttar Pradesh, and Assam. Assuming a dropout of 20% repeat screening at three months to ascertain cases, we finally enrolled 576 per site. The cluster of villages in each site with a predominantly agrarian population was identified. With approx. The number of households known for each village, and the number of villages were selected by simple random methodology. The participants who met the inclusion criteria were then invited from each village in a systematic random method. Only one individual from each household was selected. The prevalence of CKD in all three sites was between <5%.

The study bridges the existing gap in the prevalence of CKD/ CKDu among unexplored agrarian hamlets in India, and with further addition of sites, it’s likely that new hotspots of CKD/ CKDu will be uncovered. Limitations: A. Dehydration and heat stress cause a temporary increase in creatinine, which was mitigated by longitudinal measurement at three months. B. Unknown non-allopathic medications and their effect on kidney function.

Kewords