Clinical trial NCT05306327: Neurologic Physiology After Removal of Therapy (NeuPaRT)
Official title: Neurologic Physiology After Removal of Therapy (NeuPaRT): Pilot Multicentre Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Determination of Death
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include all patients admitted to a participating ICU who fulfil all the inclusion criteria and for whom none of the exclusion criteria exist.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Accrual complete study procedures)
timeFrame: 2022 to 2023
Secondary outcomes:
measure: Waveform Data Completeness
timeFrame: 2022-2023
measure: Time Difference Circulatory Arrest and Cessation of EEG Activity
timeFrame: 2022-2023
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary Foothills Campus
state: Alberta
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal,
state: Quebec
Study officials:
affiliation: London Health Sciences Centre
name: Teneille Gofton, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References: