Acute Kidney Injury Biomarkers: Diagnosis and Application in Pre-operative Period of Liver Transplantation (AKIB)

May 15, 2016 updated by: Etienne Macedo, University of Sao Paulo

Acute kidney injury (AKI), is a common complication of patients undergoing liver transplantation. Timing and definition of AKI, usually based on serum creatinine, have been inaccurate and inconsistent.

We hypothesized that the pattern of novel biomakers elevation could be a prognostic tool to provide information on the risk of progression of AKI, the need for RRT and mortality.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05320000
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients submitted to liver transplantation .

Description

Inclusion Criteria:

  • Older than 18 years
  • Reception liver transplantation

Exclusion Criteria:

  • CKD stage 4 / 5
  • Combined organ transplants
  • Patients receiving dialysis before liver transplant operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
with AKI and without AKI
development of AKI by sCr and by novel biomarkers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of Acute Kidney Injury based on novel biomarkers
Time Frame: within 7 days
Compare the timing for diagnosis of AKI comparing novel biomarkers and serum creatinine defined by Kidney Disease Improving Global Outcomes. In addition, we aim to evaluate if the pattern of elevation of the novel biomarkers provide information on progression and severity of AKI.
within 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short and long term renal outcomes
Time Frame: 1 year
renal function and need for RRT
1 year
Association of urine chemistry and microscopy to predict acute kidney injury
Time Frame: within 7 days of liver transplantation
Association of urine chemistry and microscopy with novel biomarkers to predict AKI diagnosis and progression
within 7 days of liver transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Etienne Macedo, MD, PhD, Faculty of Medicine, University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

February 7, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 24, 2014

Study Record Updates

Last Update Posted (Estimate)

May 17, 2016

Last Update Submitted That Met QC Criteria

May 15, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10393 (Registry Identifier: DAIDS ES Registry Number)
  • 2013/12710-2 (Other Grant/Funding Number: FAPESP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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