Neurologic Physiology After Removal of Therapy (NeuPaRT)

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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)

Первичные конечные точки

• Patient Accrual complete study procedures) [Срок оценки: 2022 to 2023]

Вторичные конечные точки (2)

• Waveform Data Completeness [Срок оценки: 2022-2023]
• Time Difference Circulatory Arrest and Cessation of EEG Activity [Срок оценки: 2022-2023]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Brain death or plan for Neurologic Determination of Death (NDD)
• Injuries that anatomically preclude the use of neurologic monitoring

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 5 центров

• 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

Публикации

• 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

Идентификаторы

NCT: NCT05306327 · Reda 12243

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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