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Brain Death Diagnosis at an Academic Tertiary Medical Care Center

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ClinicalTrials.gov Identifier: NCT03984981
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
The aim of this study is to assess and survey the quality of the process required to diagnose brain death in adult patients. This study of adult patients diagnosed brain dead or suspected of having brain death on the ICUs at the University Hospital Basel will be purely observational.

Condition or disease Intervention/treatment
Brain Death Other: Assessment of process required to diagnose brain death in adult patients

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Brain Death Diagnosis at an Academic Tertiary Medical Care Center
Actual Study Start Date : April 3, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Intervention Details:
  • Other: Assessment of process required to diagnose brain death in adult patients
    Assessment of process required to diagnose brain death in adult patients (demographics, clinical, laboratory, imaging, and treatment data). No questionnaires or study visits will be used.


Primary Outcome Measures :
  1. adherence to the local brain death protocol ( = measurement tool) for the process of brain death diagnosis [ Time Frame: single time point assessment at baseline (after suspected brain death) ]

    the local brain death protocol ( = measurement tool) requires 1.) exclusion of the following conditions:

    • shock (mean arterial blood pressure > 60 mmHg, lactate < 4 mmol/l)
    • hypothermia (temperature > 35°C)
    • severe acidosis (pH > 7.3)
    • hyperosmolarity (osmolarity < 320 mmol/l)
    • severe electrolyte disorders (sodium > 125 mmol/l, phosphate > 0.3 mmol/l)
    • hypoglycemia (glucose > 4 mmol/l)
    • hyperammonemia (ammonia < 60 mcmol/l)
    • uremia (urea < 25 mmol/l)
    • prolonged effects of medication (muscle relaxants, sedatives, recreational drugs)
    • severe hypothyreosis

      2.) clinical examination confirming:

    • fixed pupils (dilated or mid-dilated bilaterally)
    • absent vestibulo-ocular reflex
    • absent corneal reflex bilaterally
    • no reaction to painful stimulus bilaterally
    • absence of cough and gag reflex
    • absence of spontaneous breathing (apnea test)


Secondary Outcome Measures :
  1. number of physicians involved [ Time Frame: single time point assessment at baseline (after suspected brain death) ]
    number of physicians involved in the diagnostic procedures

  2. frequency of ancillary tests performed [ Time Frame: single time point assessment at baseline (after suspected brain death) ]
    frequency of ancillary tests (i.e. transcranial doppler ultrasound, coumputed tomography, magnetic resonance tomography, digital substraction angiography, electroencephalogram, somatosensory evoked potentials) performed

  3. number of work-ups excluding suspected brain death [ Time Frame: single time point assessment at baseline (after suspected brain death) ]
    number of work-ups excluding suspected brain death

  4. number of diagnostic work-ups with insufficient performance and/or documentation [ Time Frame: single time point assessment at baseline (after suspected brain death) ]
    number of diagnostic work-ups with insufficient performance and/or documentation

  5. years of clinical experience of physicians involved [ Time Frame: single time point assessment at baseline (after suspected brain death) ]
    years of clinical experience of physicians involved in the diagnostic procedures



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will consist of all adult (18 years or older) patients in whom brain death was suspected and/or diagnosed on the ICUs of the University Hospital Basel between January 1st 2008 and January 31st 2019.
Criteria

Inclusion Criteria:

  • patients with suspected and/or diagnosed brain death
  • adults 18 years and over

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984981


Contacts
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Contact: Raoul Sutter, PD Dr. med : 0041 (0) 61 328 79 28 raoul.sutter@usb.ch
Contact: Pascale Grzonka, Dr. med pascale.grzonka@usb.ch

Locations
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Switzerland
Clinic for Intensive Care Medicine, University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Raoul Sutter, PD Dr. med    +41 61 265 25 25    raoul.sutter@usb.ch   
Sub-Investigator: Pascale Grzonka, Dr. med         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Raoul Sutter, PD Dr. med Clinic for Intensive Care Medicine, University Hospital Basel

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03984981     History of Changes
Other Study ID Numbers: 2019-00244; me19Sutter4
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Basel, Switzerland:
diagnosis of brain death

Additional relevant MeSH terms:
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Death
Brain Death
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations