Developing and validating a formula to detect major kidney events in people with decompensated cirrhosis and ascites
Official title: To Develop and Validate an Equation for Determination of Major Adverse Kidney Events in Patients With Decompensated Cirrhosis and Ascites- A Prospective Cohort Study
Run by Institute of Liver and Biliary Sciences, India · NCT07794787 · Data updated 2026-11-12
This observational study aims to test a new equation that helps identify major adverse kidney events in adults with decompensated cirrhosis and ascites who have stable kidney function.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Status | Recruiting |
| Started | August 31, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT07794787 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 65 with cirrhosis and ascites who have had stable renal function in the past week and no AKI.
✕Probably not a fit
Patients with active kidney injury, prior liver or kidney transplant, advanced multi-organ failure, or missing critical labs may not benefit from the equation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on decompensated cirrhosis patients with ascites to develop and validate an equation that determines major adverse kidney events. It uses observational data from hospitalized adults and excludes those with prior AKI, liver or kidney transplant, or other major organ failure. The goal is to improve risk stratification for kidney-related outcomes by predicting major events such as progression to CKD or need for kidney-related interventions. The analysis will consider factors like baseline renal function and common risk factors to create a clinically usable scoring method. No interventional treatments are administered in this design.
Why it matters
Potential benefit: If successful, the equation could help clinicians identify high-risk patients early and tailor monitoring and management accordingly.
How similar studies have gone: Previous work shows strong associations between AKI in cirrhosis and mortality; however, this exact predictive equation approach is a novel or limitedly tested strategy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients of cirrhosis with ascites with stable renal functions in last 7 days (variability in gfr \< 15 % and no AKI). Exclusion Criteria: 1. Patients with age \<18 or more than 65 years 2. Obstructive uropathy or intrinsic kidney disease 3. Patients with multiorgan failure or requiring mechanical ventilation 4. Patients who had previously undergone Liver or Kidney transplant 5. Patients with missing laboratory measurements within 24 hours of admission 6. HCC 7. Pregnant 8. Lack of baseline serum creatinine 9. Need of renal replacement therapy 10. HVOTO 11. Severe comorbid cardiopulmonary diseases or extrahepatic malignancy
Where it's running
-
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India Recruiting
Study contacts
- Study coordinator: Dr Gnana Kavitha, MD
- Email: kavuluj4444@gmail.com
- Phone: 01146300000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.