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

Completed

• Conditions: Renal Failure

• Registration Number: NCT05161910
• Lead Sponsor: Asian Institute of Gastroenterology, India

Brief 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.

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-08-30
• Status Verified: 2021-11
• Study First Submitted: 2021-12-04
• Study First Submitted QC: 2021-12-04
• Study First Posted: 2021-12-17
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Cirrhosis diagnosis by combination of clinical, laboratorial, endoscopic and imaging
• Age over 18 years old
• Acute kidney injury (defined by ICA-AKI criteria)
• Agreement to participate in the study

Exclusion Criteria

• Shock/CCF
• Age less than 18yrs •
• Underwent renal replacement therapy within the last 6 week prior to evaluation
• Prior kidney or liver transplantation
• Confirmed pregnancy
• Established CKD
• Congestive cardiac failure
• Patients who have taken diuretics in the last 48 hours

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare urine Neutrophil Gelatinase Associated lipocalcin values in Hepato renal syndrome and Non-Hepato renal syndrome group.	12 months	Kidney 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)

Secondary Outcome Measures

Name	Time	Method
. To determine optimal cutoff of urine NGAL for early determination of HRS.	12 months	increase in the serum creatinine ≥ 0.3 mg/dl within 48 h or ≥ 50% from baseline value according to ICA(international club ascites) consensus document and /or urinary output ≤ 0.5 ml/kg B.W. ≥6h

Trial Locations

Locations (1)

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, Telangana, India