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Incidence of Complications of Brain Death

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04404972
Enrollment
50
Registered
2020-05-28
Start date
2022-04-01
Completion date
2023-12-01
Last updated
2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Death

Keywords

Brain Death, Organ Donation

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.

Interventions

None listed

Sponsors

Brno University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age ≥18 years * confirmed brain death * organ donor

Exclusion criteria

\- age under 18 years

Design outcomes

Primary

MeasureTime frameDescription
Hypotension48hours prior confirmation of brain death to ICU dischargeHypotension 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 level48hours prior confirmation of brain death to ICU dischargeMaximal lactate level will be evaluated during ICU stay
Catecholamine storm48hours prior confirmation of brain death to ICU dischargeCatecholamine storm is defined as onset of tachycardia and/or hypertension
Myocardial dysfunction48hours prior confirmation of brain death to ICU dischargeMyocardial 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
ARDS48hours prior confirmation of brain death to ICU dischargeARDS is defined and stratified according to Berlin definition
Oxygenation index48hours prior confirmation of brain death to ICU dischargeOxygenation index will be calculated as PaO2 divided by FiO2
Diabetes insipidus48hours prior confirmation of brain death to ICU dischargeDiabetes insipidus is defines as urine output more than 4ml/kg per hour or urine specific gravity under 1010
Renal dysfunction48hours prior confirmation of brain death to ICU dischargeRenal 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
Coagulopathy48hours prior confirmation of brain death to ICU dischargeCoagulopathy is defined as international normalised ratio above 1,5 or platelet count below 100 000 per microliter
Hypothermia48hours prior confirmation of brain death to ICU dischargeBody temperature below 36°C or need for external warming

Countries

Czechia

Contacts

Primary ContactOndrej Hrdy, MD
hrdy.ondrej@fnbrno.cz532233850
Backup ContactViktor Agalarev, MD
agalarev.viktor@fnbrno.cz532233850

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026