Incidence of Complications in Brain Death Organ Donors. Retrospective Observational Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Myocardial dysfunction
Study Overview
Brief Summary
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age ≥18 years
- •confirmed brain death
- •organ donor
Exclusion Criteria
- •age under 18 years
Outcomes
Primary Outcomes
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
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
Catecholamine storm
Time Frame: 48hours prior confirmation of brain death to ICU discharge
Catecholamine storm is defined as onset of tachycardia and/or hypertension
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
Serum lactate level
Time Frame: 48hours prior confirmation of brain death to ICU discharge
Maximal lactate level will be evaluated during ICU stay
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
Oxygenation index
Time Frame: 48hours prior confirmation of brain death to ICU discharge
Oxygenation index will be calculated as PaO2 divided by FiO2
Hypothermia
Time Frame: 48hours prior confirmation of brain death to ICU discharge
Body temperature below 36°C or need for external warming
Secondary Outcomes
No secondary outcomes reported
Investigators
Ondrej Hrdy
Principal Investigator
Brno University Hospital