Clinical Trials Directory

Trials / Completed

CompletedNCT05161910

ROLE OF URINARY BIOMARKER NEUTROPHIL GELATINASE ASSOCIATED LIPOCALCIN (NGAL) IN EARLY PREDICTION OF AKI IN CIRRHOSIS OF LIVER

Urinary Biomarker Neutrophil Gelatinase Associated Lipocalcin (NGAL) in Early Prediction of AKI in Cirrhosis of Liver

Status
Completed
Phase
Study type
Observational
Enrollment
120 (actual)
Sponsor
Asian Institute of Gastroenterology, India · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

Kidney dysfunction is a complex and common event in patients with liver cirrhosis. Although novel treatments have shown some promising results , acute kidney injury remains a major complication of decompensated liver cirrhosis with high morbidity and mortality rates . AKI occurs in up to 19-20% of hospitalized patients with liver cirrhosis and among the most frequent causes are prerenal azotemia (PRA), hepatorenal syndrome and acute tubular necrosis , with prevalence rates estimated around 68%, 25%, and 33%, respectively. The introduction and widespread use of diagnostic criteria of AKI in the area of cirrhosis has contributed to an increased awareness and earlier detection of AKI. However, some important problems remain. One of the main issues is the differential diagnosis of AKI, particularly between acute tubular necrosis (ATN) and hepatorenal syndrome (HRS-AKI). This is important because treatment is different; renal replacement therapy (RRT) is used for the former, and vasoconstrictors and albumin are used for the latter.

Detailed description

Aim of the study: To determine utility of NGAL in chronic liver disease patients with acute kidney injury. Objective: 1. To compare urine NGAL values in HRS and Non-HRS group. 2. To determine optimal cutoff of urine NGAL for early determination of HRS. Plan of investigation: All the following investigations will be done at admission for the patients who satisfy the inclusion criteria Routine blood investigations : CBP, LFT, PT- INR, RFT urine sodium on day 1 urine spot urine protein creatinine ratio CUE Urine c/s Urine NGAL Serum creatinine will be repeated on Day 3.

Conditions

Interventions

TypeNameDescription
OTHERBiomarkersKidney biomarkers appear to be useful in differential diagnosis between acute tubular necrosis (ATN) and other types of acute kidney injury (AKI) in cirrhosis, particularly hepatorenal syndrome (HRS-AKI).

Timeline

Start date
2020-03-01
Primary completion
2021-02-01
Completion
2021-08-30
First posted
2021-12-17
Last updated
2021-12-29

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT05161910. Inclusion in this directory is not an endorsement.