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Completed

NCT Number: NCT03984981

Brain Death Diagnosis at an Academic Tertiary Medical Care Center

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.

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Key information

Conditions

Brain Death Brain Diseases Central Nervous System Diseases Coma Consciousness Disorders Death Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic for Intensive Care Medicine, University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Assessment of process required to diagnose brain death in adult patients

Other

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 outcomes

  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 mumol/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 outcomes

  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, computed 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 13, 2019
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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