Incidence of Complications of Brain Death

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

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

Study Overview

• Status: Recruiting
• Conditions: Brain Death

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Ondrej Hrdy, MD; Phone Number: +420 532233850; Email: hrdy.ondrej@fnbrno.cz
• Study Contact Backup: Name: Viktor Agalarev, MD; Phone Number: +420 532233850; Email: agalarev.viktor@fnbrno.cz

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • Recruiting
    • University Hospital Brno
    • Contact: Viktor Agalarev, M.D.; Phone Number: +420532233850; Email: agalarev.viktor@fnbrno.cz
    • Contact: Ondrej Hrdy, M.D.; Phone Number: +420532233850; Email: hrdy.ondrej@fnbrno.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult critically ill patinets with confirmed brain death admitted to university hospital who become brain death organ donor.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- age under 18 years

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Investigators: Study Chair: Roman Gal, MD, PhD, University Hospital Brno

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Brain Death; Organ Donation
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Coma; Death; Brain Death
• Other Study ID Numbers: CT0012020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No