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NCT Number: NCT07794787

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Liver & Biliary Sciences (ILBS)

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

Location contact

Dr Gnana Kavitha, MD

CONTACT

[email protected]

01146300000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Major Adverse Kidney Events at 1 year.

    Time frame: 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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Gnana Kavitha, MD

CONTACT

[email protected]

01146300000

Dr Rakhi Maiwall, DM

CONTACT

[email protected]

01146300000

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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