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

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.

Study Overview

• Status: Completed
• Conditions: Renal Failure
• Intervention / Treatment: Other: Biomarkers

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Asian Institute Of Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

120

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
. 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

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Study Director: Mohan Dr Ramchandani, MBBS MD, Asian Institute Of Gastroenterology

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: December 4, 2021
• First Submitted That Met QC Criteria: December 4, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: CLD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No