Neurologic Physiology After Removal of Therapy (NeuPaRT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: electroencephalography (EEG).
- Who it may be relevant to
- Registry conditions: Determination of Death. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Neurologic Physiology After Removal of Therapy (NeuPaRT): Pilot Multicentre Feasibility Study
Overview
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.
Interventions
- Diagnostic test electroencephalography (EEG)
1. brain cortical activity using full scalp 2. cerebral blood flow velocity 3. during the dying process following planned withdrawal of life sustaining measures (WLSM)
Primary outcome measures
- Patient Accrual complete study procedures) [Time frame: 2022 to 2023]
Secondary outcome measures (2)
- Waveform Data Completeness [Time frame: 2022-2023]
- Time Difference Circulatory Arrest and Cessation of EEG Activity [Time frame: 2022-2023]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Plan for the withdrawal of life sustaining measures (WLSM)
- Attending physician anticipates patient will die within 24 hours of the withdrawal of life sustaining measures
- Patient has an indwelling arterial cannula for monitoring blood pressure
Exclusion criteria
- Brain death or plan for Neurologic Determination of Death (NDD)
- Injuries that anatomically preclude the use of neurologic monitoring
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 5 centers
- University of Calgary Foothills Campus — Calgary
- Kingston Health Sciences Centre — Kingston
- London Health Sciences Centre — London
- Ottawa Hospital — Ottawa
- Centre hospitalier de l'Université de Montréal, — Montreal
Publications
- Gofton T, Dhanani S, Meade M, Boyd JG, Chamberlain E, Chandler J, Chasse M, Scales NB, Choi YH, D'Aragon F, Debicki D, English S, Fantaneanu TA, Kramer AH, Kromm J, Murphy N, Norton L, Singh J, Smith MJ, Weijer C, Shemie S, Bentall TC, Campbell E, Slessarev M. Neurologic Physiology after Removal of Therapy (NeuPaRT) study: study protocol of a multicentre, prospective, observational, pilot feasibil PMID 37105694
Identifiers
NCT: NCT05306327 · Reda 12243