Incidence of Complications of Brain Death

NCT04404972 | Unknown

• 1 other identifier: CT0012020
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Brain Death

Keywords

Brain Death; Organ Donation

Outcome Measures

Primary Outcomes (10)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- age under 18 years

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University Hospital Brno

Brno, 62500, Czechia

RECRUITING

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roman Gal, MD, PhD

  University Hospital Brno

  STUDY CHAIR

Central Study Contacts

Ondrej Hrdy, MD

CONTACT

532233850; hrdy.ondrej@fnbrno.cz

Viktor Agalarev, MD

CONTACT

532233850; agalarev.viktor@fnbrno.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: April 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)