Incidence of Complications of Brain Death

Brain Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04404972
• Other study ID #: CT0012020
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2023
• Source: Brno University Hospital
• Contact: Ondrej Hrdy, MD
• Phone: 532233850
• Email: hrdy.ondrej[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age =18 years

• confirmed brain death

• organ donor

Exclusion Criteria:

• age under 18 years

Related Conditions & MeSH terms

• Brain Death
• Death

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

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