Clincosm LogoSign in Get a demo

AKIrisk: Biomarkers of Acute Kidney Injury in Cardiac Surgery

Sponsor
Nikola Bradic, MD (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03830450
Collaborator
(none)
50
Enrollment
25
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Biomarkers in Estimation for Risk of Acute Kidney Injury in Cardiac Surgery
    Anticipated Study Start Date :
    Dec 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Consecutive values of neutrophil gelatinase-associated lipocalin (NGAL) [One year]

      By the changing of NGAL values in consecutive measuring, predict which patients are in increased risk for development of AKI

    2. Consecutive values of growth differentiation factor 15 (GDF-15) [One year]

      By the changing of GDF-15 values in consecutive measuring, predict which patients are in increased risk for development of AKI

    3. Consecutive values of glomerular filtration rate (GFR) [One Year]

      By the changing of GFR values in consecutive measuring, predict which patients are in increased risk for development of AKI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Nikola Bradic, MD

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nikola Bradic, MD, MD, Senior Lecturer, University Hospital Dubrava
    ClinicalTrials.gov Identifier:
    NCT03830450
    Other Study ID Numbers:
    • University North
    First Posted:
    Feb 5, 2019
    Last Update Posted:
    Nov 13, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nikola Bradic, MD, MD, Senior Lecturer, University Hospital Dubrava
    Acute kidney injury
    Cardiac surgery
    NGAL
    GDF-15
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Wounds and Injuries

    Study Results

    No Results Posted as of Nov 13, 2020