Brain DeathNCT03984981
Brain Death Diagnosis at an Academic Tertiary Medical Care Center
An observational study of Brain Death, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Death
- What is being tested?
- Assessment of process required to diagnose brain death in adult patients
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Apr 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients with suspected and/or diagnosed brain death
- adults 18 years and over
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for Intensive Care Medicine, University Hospital Basel
Basel, 4031
About this study
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
- Being tested
- Assessment of process required to diagnose brain death in adult patients
- Keywords
- diagnosis of brain death
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of process required to diagnose brain death in adult patientsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: single time point assessment at baseline (after suspected brain death)
Secondary outcomes (5)
number of physicians involved
number of physicians involved in the diagnostic procedures
Measured: single time point assessment at baseline (after suspected brain death)
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
Measured: single time point assessment at baseline (after suspected brain death)
number of work-ups excluding suspected brain death
number of work-ups excluding suspected brain death
Measured: single time point assessment at baseline (after suspected brain death)
number of diagnostic work-ups with insufficient performance and/or documentation
number of diagnostic work-ups with insufficient performance and/or documentation
Measured: single time point assessment at baseline (after suspected brain death)
years of clinical experience of physicians involved
years of clinical experience of physicians involved in the diagnostic procedures
Measured: single time point assessment at baseline (after suspected brain death)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start3 Apr 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raoul Sutter, PD Dr. med, Principal investigator, Clinic for Intensive Care Medicine, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984981
- Sponsor's protocol ID
- 2019-00244; me19Sutter4
- Other IDs
- 2019
- Status last verified
- May 2021
- First submitted
- 6 May 2019
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Death Diagnosis at an Academic Tertiary Medical Care Center
- ClinicalTrials.gov ID
- NCT03984981
- Acronym / sponsor ID
- 2019-00244; me19Sutter4
- Conditions
- Brain Death
- Keywords
- diagnosis of brain death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients with suspected and/or diagnosed brain death
- adults 18 years and over
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of process required to diagnose brain death in adult patientsAssessment 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. | Other | – |
Primary outcome
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)
5 secondary outcomes
number of physicians involved
Time frame: single time point assessment at baseline (after suspected brain death)
frequency of ancillary tests performed
Time frame: single time point assessment at baseline (after suspected brain death)
number of work-ups excluding suspected brain death
Time frame: single time point assessment at baseline (after suspected brain death)
number of diagnostic work-ups with insufficient performance and/or documentation
Time frame: single time point assessment at baseline (after suspected brain death)
years of clinical experience of physicians involved
Time frame: single time point assessment at baseline (after suspected brain death)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raoul Sutter, PD Dr. med principal investigator
Clinic for Intensive Care Medicine, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Death, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.