Brain DeathNCT04404972
Incidence of Complications of Brain Death
An observational study of Brain Death, run by Brno University Hospital at 1 site in Czechia.
Trial summary
The purpose of the study is to describe the incidence of complications in brain death adult organ donors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Death
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2022to 1 Dec 2023
- 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: Adult critically ill patinets with confirmed brain death admitted to university hospital who become brain death organ donor.
Who may be able to join
- age ≥18 years
- confirmed brain death
- organ donor
Who cannot join
- age under 18 years
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Brno
Brno, 62500
Viktor Agalarev, M.D., +420532233850, agalarev.viktor@fnbrno.cz
Ondrej Hrdy, M.D., +420532233850, hrdy.ondrej@fnbrno.cz
About this study
Official title: Incidence of Complications in Brain Death Organ Donors. Retrospective Observational Study.
The purpose of the study is to describe the incidence of complications in brain death adult organ donors.
Read the detailed description
Pathophysiological changes following brain death may complicate the care of brain death donors. These complications negatively affects function of donated organs. Understanding these complications and its incidence is crucial for their appropriate management. The aim of this retrospective observational study is to evaluate the incidence of complications in adult brain death organ donors. Date will be collected from medical records of eligible patients admitted to intensive care unit for suspected brain death in whom brain death was confirmed and who become organ donors.
- Conditions
- Brain Death
- Keywords
- Brain Death, Organ Donation
- Medical subject headings
- Brain Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
Hypotension is defined as increase of vasoactive drug dose by 20% or systolic blood pressure lower than 90 mmHg or need for fluid resuscitation after initial normovolemia was achieved
Measured: 48hours prior confirmation of brain death to ICU discharge
Serum lactate level
Maximal lactate level will be evaluated during ICU stay
Measured: 48hours prior confirmation of brain death to ICU discharge
Catecholamine storm
Catecholamine storm is defined as onset of tachycardia and/or hypertension
Measured: 48hours prior confirmation of brain death to ICU discharge
Myocardial dysfunction
Myocardial dysfunction is defined as left ventricle ejection fraction under 50% on trans-thoracic echocardiography or S-T segment depression or elevation or T wave negativity or positive troponin serum level
Measured: 48hours prior confirmation of brain death to ICU discharge
ARDS
ARDS is defined and stratified according to Berlin definition
Measured: 48hours prior confirmation of brain death to ICU discharge
Oxygenation index
Oxygenation index will be calculated as PaO2 divided by FiO2
Measured: 48hours prior confirmation of brain death to ICU discharge
Diabetes insipidus
Diabetes insipidus is defines as urine output more than 4ml/kg per hour or urine specific gravity under 1010
Measured: 48hours prior confirmation of brain death to ICU discharge
Renal dysfunction
Renal dysfunction is defined as presence of at least one of these criteria: absolute increase in serum creatinine ≥0.3 mg/dL (≥26.4 μmol/L) or increase in serum creatinine ≥1.5x above baseline or oliguria (urine output <0.5 mL/kg per hour) for >6 hours
Measured: 48hours prior confirmation of brain death to ICU discharge
Coagulopathy
Coagulopathy is defined as international normalised ratio above 1,5 or platelet count below 100 000 per microliter
Measured: 48hours prior confirmation of brain death to ICU discharge
Hypothermia
Body temperature below 36°C or need for external warming
Measured: 48hours prior confirmation of brain death to ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Apr 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
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.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ondrej Hrdy, Brno University Hospital
- Investigators
- Roman Gal, MD, PhD, Study chair, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404972
- Sponsor's protocol ID
- CT0012020
- Status last verified
- Mar 2023
- First submitted
- 22 May 2020
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Complications in Brain Death Organ Donors. Retrospective Observational Study.
- ClinicalTrials.gov ID
- NCT04404972
- Acronym / sponsor ID
- CT0012020
- Conditions
- Brain Death
- Keywords
- Brain Death, Organ Donation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 28 May 2020 (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 purpose of the study is to describe the incidence of complications in brain death adult organ donors.
Detailed description
Pathophysiological changes following brain death may complicate the care of brain death donors. These complications negatively affects function of donated organs. Understanding these complications and its incidence is crucial for their appropriate management. The aim of this retrospective observational study is to evaluate the incidence of complications in adult brain death organ donors. Date will be collected from medical records of eligible patients admitted to intensive care unit for suspected brain death in whom brain death was confirmed and who become organ donors.
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
- Adult critically ill patinets with confirmed brain death admitted to university hospital who become brain death organ donor.
Key inclusion criteria (3 listed)
- age ≥18 years
- confirmed brain death
- organ donor
Key exclusion criteria (1 listed)
- age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hypotension
Time frame: 48hours prior confirmation of brain death to ICU discharge
Hypotension is defined as increase of vasoactive drug dose by 20% or systolic blood pressure lower than 90 mmHg or need for fluid resuscitation after initial normovolemia was achieved
Serum lactate level
Time frame: 48hours prior confirmation of brain death to ICU discharge
Maximal lactate level will be evaluated during ICU stay
Catecholamine storm
Time frame: 48hours prior confirmation of brain death to ICU discharge
Catecholamine storm is defined as onset of tachycardia and/or hypertension
Myocardial dysfunction
Time frame: 48hours prior confirmation of brain death to ICU discharge
Myocardial dysfunction is defined as left ventricle ejection fraction under 50% on trans-thoracic echocardiography or S-T segment depression or elevation or T wave negativity or positive troponin serum level
ARDS
Time frame: 48hours prior confirmation of brain death to ICU discharge
ARDS is defined and stratified according to Berlin definition
Oxygenation index
Time frame: 48hours prior confirmation of brain death to ICU discharge
Oxygenation index will be calculated as PaO2 divided by FiO2
Diabetes insipidus
Time frame: 48hours prior confirmation of brain death to ICU discharge
Diabetes insipidus is defines as urine output more than 4ml/kg per hour or urine specific gravity under 1010
Renal dysfunction
Time frame: 48hours prior confirmation of brain death to ICU discharge
Renal dysfunction is defined as presence of at least one of these criteria: absolute increase in serum creatinine ≥0.3 mg/dL (≥26.4 μmol/L) or increase in serum creatinine ≥1.5x above baseline or oliguria (urine output <0.5 mL/kg per hour) for >6 hours
Coagulopathy
Time frame: 48hours prior confirmation of brain death to ICU discharge
Coagulopathy is defined as international normalised ratio above 1,5 or platelet count below 100 000 per microliter
Hypothermia
Time frame: 48hours prior confirmation of brain death to ICU discharge
Body temperature below 36°C or need for external warming
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Roman Gal, MD, PhD study chair
Brno University Hospital
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 Brno University Hospital at 1 site in Czechia.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Mar 2023. 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 Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ondrej Hrdy, MD (532233850 ext. +420, hrdy.ondrej@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypotension (time frame: 48hours prior confirmation of brain death to ICU discharge). The study lists 10 primary outcomes in all. 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 28 Mar 2023.