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

NCT ID: NCT02049125

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Kidney Injury Hepatorenal Syndrome

Keywords

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NGAL Acute kidney injury Cirrhosis Hepatorenal syndrome

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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No AKI

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

No interventions assigned to this group

AKI and Infection

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

No interventions assigned to this group

AKI with No Infection

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role collaborator

Federal University of Espirito Santo

OTHER

Sponsor Role collaborator

Hospital de Base

OTHER

Sponsor Role collaborator

University of Campinas, Brazil

OTHER

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Alberto Queiroz Farias

Associate Professor of Medicine School of University of Sao Paulo

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alberto Q Farias, Associate professor

Role: STUDY_CHAIR

University of Sao Paulo

Locations

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Federal University of Espirito Santo

Vitória, Espírito Santo, Brazil

Site Status NOT_YET_RECRUITING

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

University of Campinas

Campinas, São Paulo, Brazil

Site Status NOT_YET_RECRUITING

University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Rafael O Ximenes, MD

Role: CONTACT

Phone: +55 011 2661-3338

Email: [email protected]

Facility Contacts

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Luciana L Goncalves, Ph. D.

Role: primary

Mario RA Silva, Assoc. Prof.

Role: primary

Daniel FC Mazo, PhD

Role: primary

Role: backup

Rafael O Ximenes, MD

Role: primary

Other Identifiers

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NGAL01

Identifier Type: -

Identifier Source: org_study_id