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NCT07794787
To Develop and Validate an Equation for Determination of Major Adverse Kidney Events in Patients With Decompensated Cirrhosis and Ascites.
Conditions: Decompensated Cirrhosis
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Enrollment: 400
Sponsor: Institute of Liver and Biliary Sciences, India
Location: Institute of Liver & Biliary Sciences (ILBS) New Delhi National Capital Territory of Delhi
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT07794787). StuddyBuddy aggregates publicly available trial information.