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

Renal Failure Clinical Trial

— NGAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05161910
• Other study ID #: CLD
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: November 2021
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 30, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Cirrhosis
• Renal Failure

Intervention

Other:
• 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).

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare urine Neutrophil Gelatinase Associated lipocalcin values in Hepato renal syndrome and Non-Hepato renal syndrome group.	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)	12 months
Secondary	. To determine optimal cutoff of urine NGAL for early determination of HRS.	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	12 months