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

NCT02049125 | Unknown

• 1 other identifier: NGAL01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

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.

Conditions

Acute Kidney Injury; Hepatorenal Syndrome

Keywords

NGAL; Acute kidney injury; Cirrhosis; Hepatorenal syndrome

Outcome Measures

Primary Outcomes (1)

• Accuracy of NGAL to predict no response to albumin expansion

  We will build a receiver-operating curve and calculate the area under the curve to determine the accuracy of NGAL to predict no response to albumin expansion. No response will be defined as an absence of a drop of serum creatinine to a final value below 1.5mg/dL in the day after the end of albumin expansion. Albumin will be administrated as International Ascites Club recommendations, i.e. in the dose of 1g/kg/day for 2 days in patients with suspected hepatorenal syndrome.

  One day after albumin expansion (day 3)

Secondary Outcomes (5)

• Accuracy of urinary NGAL and other biomarkers to predict no response to hepatorenal syndrome treatment

  Treatment period (maximum of 14 days)

• Accuracy of urinary NGAL and other biomarkers to predict development and progression of acute kidney injury (AKI) in patients with bacterial infection

  During antibiotic therapy and during hospital stay

• Predictors of mortality

  In-hospital, 30 days and 90 days

• Urinary NGAL as a predictor of adverse events of AKI treatment in cirrhosis

  During treatment period

• Accuracy of other biomarkers to predict no response to albumin expansion

  One day after albumin expansion (day 3)

Study Arms (3)

No AKI

Patients with cirrhosis admitted to hospital with bacterial infection with initial serum creatinine below 1.5mg/dL.

AKI and Infection

Patients with cirrhosis admitted to hospital with bacterial infection and initial serum creatinine above 1.5mg/dL.

AKI with No Infection

Patients with cirrhosis admitted to hospital with initial serum creatinine above 1.5mg/dL without bacterial infection.

Eligibility Criteria

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

Study Population

We will include cirrhotic patients admitted to hospitals participating centers with AKI and/or bacterial infection.

You may qualify if:

• 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;

You may not qualify if:

• 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;
• Previous solid organ transplantation.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Federal University of Rio Grande do Sul: collaborator
• Federal University of Espirito Santo: collaborator
• Hospital de Base: collaborator
• University of Campinas, Brazil: collaborator

Study Sites (4)

Federal University of Espirito Santo

Vitória, Espírito Santo, 29075-910, Brazil

NOT YET RECRUITING

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

University of Campinas

Campinas, São Paulo, 13083-887, Brazil

NOT YET RECRUITING

University of Sao Paulo

São Paulo, São Paulo, 05403-010, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will store samples of urine and serum frozen at -80oC.

MeSH Terms

Conditions

Acute Kidney Injury; Hepatorenal Syndrome; Fibrosis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alberto Q Farias, Associate professor

  University of Sao Paulo

  STUDY CHAIR

Central Study Contacts

Rafael O Ximenes, MD

CONTACT

+55 011 2661-3338; rximenes@gmail.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine School of University of Sao Paulo

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 29, 2014
• Study Start: June 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

BR (4)