Incidence of Complications of Brain Death

Study Overview
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Brief Summary
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The purpose of the study is to describe the incidence of complications in brain death adult organ donors.

Detailed Description
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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.

Official Title
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Incidence of Complications in Brain Death Organ Donors. Retrospective Observational Study.

Conditions
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Brain Death

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥18 years confirmed brain death organ donor Exclusion Criteria: - age under 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 48hours prior confirmation of brain death to ICU discharge | 
| Serum lactate level | Maximal lactate level will be evaluated during ICU stay | 48hours prior confirmation of brain death to ICU discharge | 
| Catecholamine storm | Catecholamine storm is defined as onset of tachycardia and/or hypertension | 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 | 48hours prior confirmation of brain death to ICU discharge | 
| ARDS | ARDS is defined and stratified according to Berlin definition | 48hours prior confirmation of brain death to ICU discharge | 
| Oxygenation index | Oxygenation index will be calculated as PaO2 divided by FiO2 | 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 | 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 | 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 | 48hours prior confirmation of brain death to ICU discharge | 
| Hypothermia | Body temperature below 36°C or need for external warming | 48hours prior confirmation of brain death to ICU discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Death, Organ Donation