An observational study in Brain Death, sponsored by Brno University Hospital. Status unknown at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by Brno University Hospital · Observational
The purpose of the study is to describe the incidence of complications in brain death adult organ donors.
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.
74 studies on the registry are indexed under Brain Death; 10 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 33 observational studies indexed under Brain Death.
Browse Brain Death studies →Brno University Hospital is the lead sponsor of 91 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult critically ill patinets with confirmed brain death admitted to university hospital who become brain death organ donor.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Time frame: 48hours prior confirmation of brain death to ICU discharge
Serum lactate level
Maximal lactate level will be evaluated during ICU stay
Time frame: 48hours prior confirmation of brain death to ICU discharge
Catecholamine storm
Catecholamine storm is defined as onset of tachycardia and/or hypertension
Time frame: 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
Time frame: 48hours prior confirmation of brain death to ICU discharge
ARDS
ARDS is defined and stratified according to Berlin definition
Time frame: 48hours prior confirmation of brain death to ICU discharge
Oxygenation index
Oxygenation index will be calculated as PaO2 divided by FiO2
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 48hours prior confirmation of brain death to ICU discharge
Hypothermia
Body temperature below 36°C or need for external warming
Time frame: 48hours prior confirmation of brain death to ICU discharge
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2022 (actual). Primary completion is estimated for Dec 2023, 20 months after the start.
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This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Brno University Hospital