Study of Accuracy of NGAL, a Renal Injury Biomarker, in Patients With Cirrhosis

University of Sao Paulo

Status

Unknown

Conditions

Acute Kidney Injury

Hepatorenal Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT02049125

NGAL01

Details and patient eligibility

About

The purpose of this study is to test the accuracy of urinary neutrophil-gelatinase associated lipocalin (NGAL) and other biomarkers (plasma renin, norepinephrine) to predict acute kidney injury (AKI) development in patients with cirrhosis and bacterial infection and to predict response to AKI treatment with albumin and albumin with terlipressin in patients with suspected hepatorenal syndrome.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Cirrhosis diagnosis by liver biopsy or combination of clinical, laboratorial, endoscopic and imagenological data;
Presence of ascites and/or hepatic hydrothorax;
Age over 18 years old;
Diagnosis of bacterial infection (including spontaneous bacterial peritonitis and others) with or without acute kidney injury (defined as a serum creatinine above 1.5mg/dL at admission) or acute kidney injury without bacterial infection;
Agreement to participate in the study, registered by informed consent;

Exclusion criteria

Serious comorbidities (functional class IV heart failure, O2 dependent chronic obstructive pulmonary disease, advanced cancer);
Shock, as defined by American College of Chest Physicians;
Chronic kidney disease with serum creatinine persistently above 1.5mg/dL in the previous 6 months and/or with sonographic findings of chronic nephropathy;
Intrinsic nephropathy with hematuria over 50 red cells/high power field and dysmorphic erythrocyte and/or proteinuria over 500mg/24h;
Use of nephrotoxic drugs in the previous 30 days;
Dialysis prior to study inclusion;
Previous solid organ transplantation.