Brain Death Diagnosis at an Academic Tertiary Medical Care Center

Brain Death Clinical Trial

Official title:

Brain Death Diagnosis at an Academic Tertiary Medical Care Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03984981
• Other study ID #: 2019-00244; me19Sutter4
• Status: Completed
• Start date: April 3, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with suspected and/or diagnosed brain death

• adults 18 years and over

Related Conditions & MeSH terms

• Brain Death
• Death

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Clinic for Intensive Care Medicine, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	number of physicians involved	number of physicians involved in the diagnostic procedures	single time point assessment at baseline (after suspected brain death)
Secondary	frequency of ancillary tests performed	frequency of ancillary tests (i.e. transcranial doppler ultrasound, computed tomography, magnetic resonance tomography, digital substraction angiography, electroencephalogram, somatosensory evoked potentials) performed	single time point assessment at baseline (after suspected brain death)
Secondary	number of work-ups excluding suspected brain death	number of work-ups excluding suspected brain death	single time point assessment at baseline (after suspected brain death)
Secondary	number of diagnostic work-ups with insufficient performance and/or documentation	number of diagnostic work-ups with insufficient performance and/or documentation	single time point assessment at baseline (after suspected brain death)
Secondary	years of clinical experience of physicians involved	years of clinical experience of physicians involved in the diagnostic procedures	single time point assessment at baseline (after suspected brain death)