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

NCT05161910 | Completed DMC

• 1 other identifier: CLD
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  12 months

Interventions

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).

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

120

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

• Mohan Dr Ramchandani, MBBS MD

  Asian Institute of Gastroenterology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 4, 2021
• First Posted: December 17, 2021
• Study Start: March 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: August 30, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)