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Postoperative Delirium After Kidney Transplantation

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT05887076
Collaborator
(none)
400
Enrollment
2
Locations
6.3
Anticipated Duration (Months)
200
Patients Per Site
31.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This project is a retrospective evaluation of the routine data of patients who underwent a kidney transplant at the Charité Campus Mitte between January 2015 and December 2019 (until the corona pandemic).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Post-anesthetic complications such as delirium can occur in patients after kidney transplantation. We would therefore like to characterize pathophysiological changes after transplantation of the kidneys and, if necessary, gain diagnostic and therapeutic knowledge. The purpose is to study postoperative delirium after kidney transplantation.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Postoperative Delirium After Kidney Transplantation
    Actual Study Start Date :
    May 24, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of delirium [2015 - 2019]

      Incidence of delirium is recorded from validated delirium scores.

    Secondary Outcome Measures

    1. Duration of delirium [2015 - 2019]

      Duration of delirium is recorded in days.

    2. Severity of delirium [2015 - 2019]

      Severity of delirium is recorded from validated delirium scores.

    3. Intraoperative parameter [2015 - 2019]

      Intraoperative parameter are recorded from patients with delirium.

    4. Anesthesia [2015 - 2019]

      Anesthesia is recorded from patient files of patients with delirium.

    5. Anesthesiological parameters [2015 - 2019]

      Anesthesiological parameters are recorded from patient files of patients with delirium.

    6. Immunosupressive therapy [2015 - 2019]

      Immunosupressive therapy is recorded in patients with delirium.

    7. Delirium treatment [2015 - 2019]

      Delirium treatment is recorded peri-operatively.

    8. Pain teatment [2015 - 2019]

      Pain treatment is recorded peri-operatively.

    9. Intensive care unit stay [2015 - 2019]

      Length of intensive care unit stay is measured in days.

    10. Hospital stay [2015 - 2019]

      Length of hospital stay is measured in days.

    11. Mortality [2015 - 2019]

      Mortality is measured within the hospital

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients 18 years and older who underwent kidney transplantation and who were admitted to Post-intensive care unit or to an Intensive care unit at the Campus Charité Mitte
    Exclusion Criteria:

    • Incomplete data records of the parameters to be determined

    • Underage Patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anaesthesiology and Intensive Care Medicine CCM, Charite - Universitätsmedizin Berlin Germany 10117
    2 Medical Clinic with a focus on Nephrology and Internal Intensive Care Medicine Berlin Germany 10117

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Claudia Spies, Head of the Department of Anaesthesiology and Intensive Care Medicine CCM/CVK, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT05887076
    Other Study ID Numbers:
    • PODNTX
    First Posted:
    Jun 2, 2023
    Last Update Posted:
    Jun 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
    Additional relevant MeSH terms:
    Delirium
    Emergence Delirium

    Study Results

    No Results Posted as of Jun 5, 2023