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

NCT ID: NCT05161910

Last Updated: 2021-12-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-08-30

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.

Conditions

Renal Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Biomarkers

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asian Institute of Gastroenterology, India

OTHER

Sponsor Role: lead

Responsible Party

Mohan Ramchandani

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohan Dr Ramchandani, MBBS MD

Role: STUDY_DIRECTOR

Asian Institute of Gastroenterology

Locations

Asian Institute of Gastroenterology

Hyderabad, Telangana, India

Countries

India

Other Identifiers

CLD

Identifier Type: -

Identifier Source: org_study_id