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RecruitingNCT07794787Updated Sep 18, 2026

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

An observational study in Decompensated Cirrhosis, sponsored by Institute of Liver and Biliary Sciences, India. Recruiting at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Institute of Liver and Biliary Sciences, India · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 65 Years
Sex
All
01

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
02

Conditions studied

  • Decompensated Cirrhosis
03

In context

Lead sponsor

Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.

Browse Institute of Liver and Biliary Sciences, India studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with cirrhosis and ascites admitted in ILBS.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cirrhosis with ascites

    Patients with cirrhosis and ascites admitted in ILBS.

06

What researchers measure

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.

    Time frame: 1 year

Secondary outcomes

  1. Validation and comparision of new equation with known equations of GFR

    Time frame: 1 year

  2. Cumulative incidence of AKI and its impact on MAKE

    Time frame: 1 year

  3. AKD and CKD development

    Time frame: 1 year

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

    Time frame: 1 year

  5. Need for Liver transplant or simultaneous liver kidney transplant

    Time frame: 1 year

  6. Numbers of hospitalisations

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07794787
Lead sponsor
Institute of Liver and Biliary Sciences, India
Responsible party
Sponsor
First posted
Aug 31, 2026
Start date
Aug 31, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 18, 2026

Study contacts

Dr Gnana Kavitha, MD
Contact
kavuluj4444@gmail.com
01146300000
Dr Rakhi Maiwall, DM
Contact
rakhi_2011@yahoo.co.in
01146300000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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