Neurologic Physiology After Removal of Therapy (NeuPaRT)

Determination of Death Clinical Trial

— NeuPaRT  

Official title:

Neurologic Physiology After Removal of Therapy (NeuPaRT): Pilot Multicentre Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05306327
• Other study ID #: Reda 12243
• Status: Recruiting
• Start date: October 18, 2022
• Est. completion date: September 2025

Study information

• Verified date: January 2024
• Source: Lawson Health Research Institute
• Contact: Teneille Gofton
• Phone: 519-663-2911
• Email: teneille.gofton[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine when brain function stops compared to when the heart stops by monitoring electrical brain activity in patients who are taken off life support and progress to death in the intensive care unit.

Description:

There are many Canadians who need an organ transplant and who will never get one. In the past, people could only be organ donors after being declared brain dead.

The dead donor rule serves this purpose by ensuring that death determination precedes organ retrieval. In Canada, death determination occurs in one of two ways. In neurologic determination of death (NDD), death is declared upon completion of a standardized neurologic assessment that confirms permanent loss of brain activity. In donation after circulatory determination of death (DCDD), death is declared 5 minutes after circulatory arrest. By confirming permanent loss of brain activity, the current NDD process protects donors from suffering and maintains stakeholder trust. In contrast, the current DCDD process assumes, but does not explicitly confirm, permanent loss of brain activity when death is declared 5 minutes after circulatory arrest. While this assumption is rooted in a strong physiologic rationale, lack of compelling evidence regarding cessation of brain activity in humans contributes to ongoing mistrust of the DCDD process among healthcare and public stakeholders.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Plan for the withdrawal of life sustaining measures (WLSM)

3. Attending physician anticipates patient will die within 24 hours of the withdrawal of life sustaining measures

4. Patient has an indwelling arterial cannula for monitoring blood pressure

Exclusion Criteria:

1. Brain death or plan for Neurologic Determination of Death (NDD)

2. Injuries that anatomically preclude the use of neurologic monitoring

Related Conditions & MeSH terms

• Death
• Determination of Death

Intervention

Diagnostic Test:
• electroencephalography (EEG)
brain cortical activity using full scalp cerebral blood flow velocity during the dying process following planned withdrawal of life sustaining measures (WLSM)

Locations

Country	Name	City	State
Canada	University of Calgary Foothills Campus	Calgary	Alberta
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Centre hospitalier de l'Université de Montréal,	Montréal	Quebec
Canada	Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Accrual complete study procedures)	90 patients at all sites and an additional 18 patients at the lead site for specific tests	2022 to 2023
Secondary	Waveform Data Completeness	Adequate waveform signal that (i) spans circulatory arrest, (ii) includes data for at least 80% of the planned observation period (from the withdrawal of life sustaining measures to 30 minutes after circulatory arrest [or 5 minutes for confirmed donation after circulatory determination of death (DCDD) donors]), and (iii) has a clearly identifiable time of cessation for each signal.	2022-2023
Secondary	Time Difference Circulatory Arrest and Cessation of EEG Activity	Cerebral blood flow velocity in middle cerebral artery (when available), and cessation of event/evoked potentials (LHSC site only). See below for definition of cessation of each signal.	2022-2023