Brain Death Diagnosis at an Academic Tertiary Medical Care Center

NCT03984981 | Completed

• 1 other identifier: 2019-00244; me19Sutter4
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Death

Keywords

diagnosis of brain death

Outcome Measures

Primary Outcomes (1)

• adherence to the local brain death protocol ( = measurement tool) for the process of brain death diagnosis

  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)

  single time point assessment at baseline (after suspected brain death)

Secondary Outcomes (5)

• number of physicians involved

  single time point assessment at baseline (after suspected brain death)

• frequency of ancillary tests performed

  single time point assessment at baseline (after suspected brain death)

• number of work-ups excluding suspected brain death

  single time point assessment at baseline (after suspected brain death)

• number of diagnostic work-ups with insufficient performance and/or documentation

  single time point assessment at baseline (after suspected brain death)

• years of clinical experience of physicians involved

  single time point assessment at baseline (after suspected brain death)

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Clinic for Intensive Care Medicine, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

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

Study Officials

• Raoul Sutter, PD Dr. med

  Clinic for Intensive Care Medicine, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: June 13, 2019
• Study Start: April 3, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

CH (1)