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

Acute Kidney Injury Clinical Trial

Official title:

Urinary Biomarker NGAL in Decompensated Cirrhosis: Early Prediction of AKI and of Treatment Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02049125
• Other study ID #: NGAL01
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2014
• Last updated: October 25, 2016
• Start date: June 2013
• Est. completion date: March 2018

Study information

• Verified date: October 2016
• Source: University of Sao Paulo
• Contact: Rafael O Ximenes, MD
• Phone: +55 011 2661-3338
• Email: rximenes[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Fibrosis
• Hepatorenal Syndrome
• Liver Cirrhosis
• Wounds and Injuries

Locations

Country	Name	City	State
Brazil	University of Campinas	Campinas	São Paulo
Brazil	Federal University of Rio Grande do Sul	Porto Alegre	Rio Grande do Sul
Brazil	University of Sao Paulo	Sao Paulo
Brazil	Federal University of Espirito Santo	Vitoria	Espirito Santo

Sponsors (5)

Lead Sponsor	Collaborator
University of Sao Paulo	Federal University of Espirito Santo, Federal University of Rio Grande do Sul, Hospital de Base, University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Accuracy of urinary NGAL and other biomarkers to predict no response to hepatorenal syndrome treatment	We will test the accuracy of urinary NGAL and other biomarkers to predict no response to hepatorenal syndrome treatment. No response to treatment will be defined as a final value of serum creatinine above 1.5mg/dL after the end of treatment with terlipressin plus albumin. The treatment will be conducted according to International Ascites Club recommendations.	Treatment period (maximum of 14 days)	No
Secondary	Accuracy of urinary NGAL and other biomarkers to predict development and progression of acute kidney injury (AKI) in patients with bacterial infection	We will test the accuracy of urinary NGAL and other biomarkers to predict AKI development and progression during antibiotic therapy and during hospital stay in patients with bacterial infection. AKI will be defined by ICA-AKI criteria.	During antibiotic therapy and during hospital stay	No
Secondary	Predictors of mortality	We will test clinical and laboratorial data relationship with in-hospital, 30 days and 90 days mortality in a univariate analysis. Associated variables will be tested in a multivariate analysis.	In-hospital, 30 days and 90 days	No
Secondary	Urinary NGAL as a predictor of adverse events of AKI treatment in cirrhosis	We will build a receiver-operating curve and calculate the area under the curve to determine the accuracy of urinary NGAL to predict adverse events during AKI treatment with albumin alone or in combination with terlipressin. We will also calculate the best cut-off value based on the receiver-operating curve.	During treatment period	Yes
Secondary	Accuracy of other biomarkers to predict no response to albumin expansion	We will test the accuracy of other biomarkers 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)	No