Clinical trial NCT02049125: Study of Accuracy of NGAL, a Renal Injury Biomarker, in Patients With Cirrhosis
Official title: Urinary Biomarker NGAL in Decompensated Cirrhosis: Early Prediction of AKI and of Treatment Response
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Hepatorenal Syndrome
Keywords: NGAL
Acute kidney injury
Cirrhosis
Hepatorenal syndrome
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
name: Federal University of Espirito Santo
name: Hospital de Base
name: University of Campinas, Brazil
First posted: 2014-01-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will include cirrhotic patients admitted to hospitals participating centers with AKI and/or bacterial infection.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of NGAL to predict no response to albumin expansion
timeFrame: One day after albumin expansion (day 3)
Secondary outcomes:
measure: Accuracy of urinary NGAL and other biomarkers to predict no response to hepatorenal syndrome treatment
timeFrame: Treatment period (maximum of 14 days)
measure: Accuracy of urinary NGAL and other biomarkers to predict development and progression of acute kidney injury (AKI) in patients with bacterial infection
timeFrame: During antibiotic therapy and during hospital stay
measure: Predictors of mortality
timeFrame: In-hospital, 30 days and 90 days
measure: Urinary NGAL as a predictor of adverse events of AKI treatment in cirrhosis
timeFrame: During treatment period
measure: Accuracy of other biomarkers to predict no response to albumin expansion
timeFrame: One day after albumin expansion (day 3)
Other outcomes:
Locations:
city: Vitoria
country: Brazil
facility: Federal University of Espirito Santo
state: Espirito Santo
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul
state: Rio Grande do Sul
city: Campinas
country: Brazil
facility: University of Campinas
state: São Paulo
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Alberto Q Farias, Associate professor
role: STUDY_CHAIR
References: