Incidence of Complications of Brain Death

Sponsor
Brno University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04404972
Collaborator
(none)
50
1
6
8.3

Study Details

Study Description

Brief Summary

The purpose of the study is to describe the incidence of complications in brain death adult organ donors.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Pathophysiological changes following brain death may complicate the care of brain death donors. These complications negatively affects function of donated organs. Understanding these complications and its incidence is crucial for their appropriate management. The aim of this retrospective observational study is to evaluate the incidence of complications in adult brain death organ donors. Date will be collected from medical records of eligible patients admitted to intensive care unit for suspected brain death in whom brain death was confirmed and who become organ donors.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Incidence of Complications in Brain Death Organ Donors. Retrospective Observational Study.
    Actual Study Start Date :
    Apr 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Oct 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Hypotension [48hours prior confirmation of brain death to ICU discharge]

      Hypotension is defined as increase of vasoactive drug dose by 20% or systolic blood pressure lower than 90 mmHg or need for fluid resuscitation after initial normovolemia was achieved

    2. Serum lactate level [48hours prior confirmation of brain death to ICU discharge]

      Maximal lactate level will be evaluated during ICU stay

    3. Catecholamine storm [48hours prior confirmation of brain death to ICU discharge]

      Catecholamine storm is defined as onset of tachycardia and/or hypertension

    4. Myocardial dysfunction [48hours prior confirmation of brain death to ICU discharge]

      Myocardial dysfunction is defined as left ventricle ejection fraction under 50% on trans-thoracic echocardiography or S-T segment depression or elevation or T wave negativity or positive troponin serum level

    5. ARDS [48hours prior confirmation of brain death to ICU discharge]

      ARDS is defined and stratified according to Berlin definition

    6. Oxygenation index [48hours prior confirmation of brain death to ICU discharge]

      Oxygenation index will be calculated as PaO2 divided by FiO2

    7. Diabetes insipidus [48hours prior confirmation of brain death to ICU discharge]

      Diabetes insipidus is defines as urine output more than 4ml/kg per hour or urine specific gravity under 1010

    8. Renal dysfunction [48hours prior confirmation of brain death to ICU discharge]

      Renal dysfunction is defined as presence of at least one of these criteria: absolute increase in serum creatinine ≥0.3 mg/dL (≥26.4 μmol/L) or increase in serum creatinine ≥1.5x above baseline or oliguria (urine output <0.5 mL/kg per hour) for >6 hours

    9. Coagulopathy [48hours prior confirmation of brain death to ICU discharge]

      Coagulopathy is defined as international normalised ratio above 1,5 or platelet count below 100 000 per microliter

    10. Hypothermia [48hours prior confirmation of brain death to ICU discharge]

      Body temperature below 36°C or need for external warming

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • age ≥18 years

    • confirmed brain death

    • organ donor

    Exclusion Criteria:
    • age under 18 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Brno Brno Czechia 62500

    Sponsors and Collaborators

    • Brno University Hospital

    Investigators

    • Study Chair: Roman Gal, MD, PhD, University Hospital Brno

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ondrej Hrdy, Principal Investigator, Brno University Hospital
    ClinicalTrials.gov Identifier:
    NCT04404972
    Other Study ID Numbers:
    • CT0012020
    First Posted:
    May 28, 2020
    Last Update Posted:
    May 5, 2022
    Last Verified:
    May 1, 2022
    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 Ondrej Hrdy, Principal Investigator, Brno University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 5, 2022