- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03830450
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
Conditions
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
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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