Skip to main content
OpenTrials
Completed

NCT Number: NCT05161910

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

About this study

Aim of the study:

To determine utility of NGAL in chronic liver disease patients with acute kidney injury.

Objective:

  • To compare urine NGAL values in HRS and Non-HRS group.
  • 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Biomarkers

Other

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).

Primary outcomes

  1. To compare urine Neutrophil Gelatinase Associated lipocalcin values in Hepato renal syndrome and Non-Hepato renal syndrome group.

    Time frame: 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 outcomes

  1. . To determine optimal cutoff of urine NGAL for early determination of HRS.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

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

Acronym: NGAL

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2021
Registry last updated
Dec 29, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.