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NEUKID: Role of Neuronal Guidance Proteins as Diagnostic Markers for Acute Kidney Injury (AKI)

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05924269
Collaborator
(none)
600
Enrollment
35
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Acute kidney failure remains one of the most challenging entities to diagnose in clinical medicine, especially in the field of intensive care. The diagnosis of acute kidney injury is based solely on urine output and serum creatinine, both of which could also be influenced by other factors. A more sensitive and faster diagnostic option would not only be desirable but of utmost clinical importance. Therefore, the investigators aim to identify Neuronal Guidance Proteins (NGPs) as potential biomarkers for the identification and early detection of AKI with this investigation. This investigation aims to identify the possibility of diagnosing acute kidney injury, the subsequent validation of a potential biomarker will then have to take place in a multicenter study approach: Data in preclinical mouse models suggest that SEMA7A as one of the NGPs could be valuable as a biomarker, the study now aims to attempt a preliminary survey in humans and measure various NGPs.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Role of Neuronal Guidance Proteins as Diagnostic Markers for Acute Kidney Injury (AKI)
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Jul 1, 2026
    Anticipated Study Completion Date :
    Jul 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    Cardiac Surgery

    Patients undergoing cardiac surgery

    Outcome Measures

    Primary Outcome Measures

    1. AKI [1-7 days]

      Development of AKI after cardiac surgery

    Secondary Outcome Measures

    1. NGP [1-7 days]

      Concentration of NGPs in Blood and Urine

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients undergoing cardiac surgery

    • written consent

    Exclusion Criteria:

    • no written consent possible

    • Polytrauma, severe burns

    • Immunosuppression

    • Pregnancy

    • Diagnosis of Hepatitis B, Hepatitis C, and/or HIV

    • Sepsis

    • Pre-existing kidney damage

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital Tuebingen

    Investigators

    • Principal Investigator: Andreas Körner, MD, University Clinic of Tuebingen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Tuebingen
    ClinicalTrials.gov Identifier:
    NCT05924269
    Other Study ID Numbers:
    • NEUKID
    First Posted:
    Jun 29, 2023
    Last Update Posted:
    Jul 5, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital Tuebingen
    Neuronal Guidance Protein
    Acute Kidney Injury
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Wounds and Injuries

    Study Results

    No Results Posted as of Jul 5, 2023