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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with cirrhosis and ascites admitted in ILBS.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 1 trial group
Group A: Cirrhosis with ascites

Trial outcomes

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

Other outcomes

Sponsors and contacts

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