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

NCT07794787 | Recruiting

• 1 other identifier: ILBS-Cirrhosis-77
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Major Adverse Kidney Events at 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.

  1 year

Secondary Outcomes (6)

• Validation and comparision of new equation with known equations of GFR

  1 year

• Cumulative incidence of AKI and its impact on MAKE

  1 year

• AKD and CKD development

  1 year

• Development of Liver related decompensating events: worsening of ascites, acute Variceal bleed,SBP and non-SBP infections, hepatic encephalopathy,Hepatocellular carcinoma

  1 year

• Need for Liver transplant or simultaneous liver kidney transplant

  1 year

Study Arms (1)

Cirrhosis with ascites

Patients with cirrhosis and ascites admitted in ILBS.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cirrhosis and ascites admitted in ILBS.

You may qualify if:

• Patients of cirrhosis with ascites with stable renal functions in last 7 days (variability in gfr \< 15 % and no AKI).

You may not qualify if:

• Patients with age \<18 or more than 65 years
• Obstructive uropathy or intrinsic kidney disease
• Patients with multiorgan failure or requiring mechanical ventilation
• Patients who had previously undergone Liver or Kidney transplant
• Patients with missing laboratory measurements within 24 hours of admission
• HCC
• Pregnant
• Lack of baseline serum creatinine
• Need of renal replacement therapy
• HVOTO
• Severe comorbid cardiopulmonary diseases or extrahepatic malignancy

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

Central Study Contacts

Dr Gnana Kavitha, MD

CONTACT

01146300000; kavuluj4444@gmail.com

Dr Rakhi Maiwall, DM

CONTACT

01146300000; rakhi_2011@yahoo.co.in

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-08

Locations

IN (1)