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Clinical Trials in India / NCT07794787
Recruiting Observational

To Develop and Validate an Equation for Determination of Major Adverse Kidney Events in Patients With Decompensated Cirrhosis and Ascites.

NCT07794787 · tracked via the Priya Life Science India tracker
Sponsor
Institute of Liver and Biliary Sciences, India
Phase
Observational
Started
2026-08-31
Last updated
2026-09-18

Condition(s) studied

Decompensated Cirrhosis

Study summary

Acute kidney injury (AKI) is the sudden loss of kidney function that occurs frequently in hospitalised patients with cirrhosis.

* It develops in up to 53% and is independently associated with high short-term mortality.
* A diagnosis of AKI (even stage 1 AKI) has been shown to be associated with an increased risk of long-term mortality at 30-day, 90-day and 1-year, compared to patients without AKI, even when there is recovery of AKI.
* Risk factors with the strongest association for developing AKI include CKD, sepsis, spontaneous bacterial peritonitis (SBP), and presence of ascites.
* AKI in cirrhosis is also associated with development of de-novo chronic kidney disease (CKD) , progressive loss of kidney function in patients with pre-existing CKD,recurrent AKI (i.e., AKI on top of CKD) and other organ failures
* Kidney dysfunction in patients with cirrhosis is associated with a marked increase in mortality compared with patients without kidney dysfunction.
* The accurate estimation of kidney function in patients with cirrhosis is hence crucial for prognosis, treatment strategies, and decisions regarding simultaneous liver-kidney transplantation (SLKT).
* Although measured GFR(mGFR) may be ideal for assessing kidney function, it is costly, time-consuming, and challenging to perform frequently in fluctuating kidney function. Therefore, GFR is most commonly estimated using serum creatinine (sCr)-based or cystatin C (CysC)-based equations

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Major Adverse Kidney Events at 1 year. — 1 year
    Make is defined as the composite outcome of ≥25% decline in estimated-glomerular-filtration-rate (eGFR) compared with baseline with the development of de-novo chronic-kidney-disease (CKD) stage ≥3 or CKD progression (≥50% reduction in eGFR compared with baseline or new haemodialysis or death.

Trial sites (1)

FacilityCityRegionStatus
Institute of Liver & Biliary Sciences (ILBS) New Delhi National Capital Territory of Delhi Recruiting

More Institute of Liver and Biliary Sciences, India trials in India

Comparison of Safety and Efficacy of Tailored Versus Fixed Dose Albumin for the Management of Patients With Cirrhosis and Sepsis Associated Acute Kidney Injury Starting soon
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Thalidomide Versus Argon Plasma Coagulation in Gastric Antral Vascular Ectasia(GAVE)-Related Anaemia in Cirrhosis (TAG Trial) Starting soon
Magnetic Resonance Cholangiopancreatography in Living Liver Donors and Its Relationship With Post Operative Recipient Biliary Complications Recruiting
Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis Starting soon

Other trials for the same condition

Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival Recruiting
BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE Recruiting
National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Single vs Repeated Cycle of Granulocyte Colony-Stimulating Factor (GCSF) & Darbepoetin in Early Decompensated Cirrhosis Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07794787 on ClinicalTrials.gov ↗ ← All trials in India