Skip to content

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

To Develop and Validate an Equation for Determination of Major Adverse Kidney Events in Patients With Decompensated Cirrhosis and Ascites- A Prospective Cohort Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07794787
Enrollment
400
Registered
2026-08-31
Start date
2026-08-31
Completion date
2026-12-31
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decompensated Cirrhosis

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

Interventions

None listed

Sponsors

Institute of Liver and Biliary Sciences, India
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
Major Adverse Kidney Events at 1 year.1 yearMake 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.

Secondary

MeasureTime frame
Validation and comparision of new equation with known equations of GFR1 year
Cumulative incidence of AKI and its impact on MAKE1 year
AKD and CKD development1 year
Development of Liver related decompensating events: worsening of ascites, acute Variceal bleed,SBP and non-SBP infections, hepatic encephalopathy,Hepatocellular carcinoma1 year
Need for Liver transplant or simultaneous liver kidney transplant1 year
Numbers of hospitalisations1 year

Countries

India

Contacts

CONTACTDr Gnana Kavitha, MD
kavuluj4444@gmail.com01146300000
CONTACTDr Rakhi Maiwall, DM
rakhi_2011@yahoo.co.in01146300000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026