Neurologic Physiology After Removal of Therapy (NeuPaRT)

Recruiting

• Conditions: Determination of Death

• Registration Number: NCT05306327
• Lead Sponsor: Lawson Health Research Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-04-01
• Study Start: 2022-10-18
• Status Verified: 2024-01
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-03
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Accrual complete study procedures)	2022 to 2023	90 patients at all sites and an additional 18 patients at the lead site for specific tests

Secondary Outcome Measures

Name	Time	Method
Waveform Data Completeness	2022-2023	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.
Time Difference Circulatory Arrest and Cessation of EEG Activity	2022-2023	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.

Trial Locations

Locations (5)

University of Calgary Foothills Campus; 🇨🇦 Calgary, Alberta, Canada

Kingston Health Sciences Centre; 🇨🇦 Kingston, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Centre hospitalier de l'Université de Montréal,; 🇨🇦 Montréal, Quebec, Canada