Biomarkers of Acute Kidney Injury in Cardiac Surgery (AKIrisk)

November 10, 2020 updated by: Nikola Bradic, MD

Biomarkers in Estimation for Risk of Acute Kidney Injury in Cardiac Surgery

Acute kidney injury (AKI) is the most common complication in patients after cardiac surgery. An usual estimation of risk for AKI is estimation of serum creatinine, which is unreliable indicator of AKI risk. Because of that, today different biomarkers are investigated to predict incidence for development AKI after cardiac surgery. This investigation will try to find potentially risk patients for developing AKI after cardiac surgery by using conventional markers (creatinine, glomerular filtration rate) in perioperative period comparing with two different biomarkers neutrophil gelatinase-associated lipocalin (NGAL) and growth differentiation factor 15 (GDF-15) which are proven markers in patients with increased risk for AKI development.

Study Overview

Status

Unknown

Study Type

Observational

Enrollment (Anticipated)

50

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

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients scheduled for cardiac surgery with usage of cardiopulmonary bypass

Description

Inclusion Criteria:

  • patients scheduled for cardiac surgery (CABG, valve replacement/repair, combined)
  • older than 18 years

Exclusion Criteria:

  • previous known renal disease
  • patients on chronic dialysis

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consecutive values of neutrophil gelatinase-associated lipocalin (NGAL)
Time Frame: One year
By the changing of NGAL values in consecutive measuring, predict which patients are in increased risk for development of AKI
One year
Consecutive values of growth differentiation factor 15 (GDF-15)
Time Frame: One year
By the changing of GDF-15 values in consecutive measuring, predict which patients are in increased risk for development of AKI
One year
Consecutive values of glomerular filtration rate (GFR)
Time Frame: One Year
By the changing of GFR values in consecutive measuring, predict which patients are in increased risk for development of AKI
One Year

Collaborators and Investigators

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

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 (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

February 2, 2019

First Submitted That Met QC Criteria

February 2, 2019

First Posted (Actual)

February 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • University North

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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