NCT05306327

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Oct 2022Mar 2027

First Submitted

Initial submission to the registry

March 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

October 18, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

4.4 years

First QC Date

March 23, 2022

Last Update Submit

January 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Waveform Data Completeness

    2022-2023

  • Time Difference Circulatory Arrest and Cessation of EEG Activity

    2022-2023

Interventions

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)

Also known as: transcranial Doppler (TCD), related (EP), somatosensory (SSEP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Calgary Foothills Campus

Calgary, Alberta, T2N1N4, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L2V7, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

RECRUITING

Centre hospitalier de l'Université de Montréal,

Montreal, Quebec, H2X3E4, Canada

RECRUITING

Related Publications (1)

  • 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 feasibility study of neurophysiology after withdrawal of life-sustaining measures. BMJ Open. 2023 Apr 27;13(4):e073643. doi: 10.1136/bmjopen-2023-073643.

MeSH Terms

Conditions

Death

Interventions

ElectroencephalographyUltrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisEchoencephalographyNeuroradiographyNeuroimagingDiagnostic ImagingRadiographyUltrasonographyUltrasonography, DopplerInvestigative Techniques

Study Officials

  • Teneille Gofton, MD MSc FRCPC

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2022

First Posted

April 1, 2022

Study Start

October 18, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Requests for data sharing should be directed to the principal investigator (Dr. T. Gofton) and will be considered on a case by case basis and with approval from the Western Health Sciences Research Ethics Board. No video will be shared at any time.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After completion of data analysis (5 years after study initiation August 2022)

Locations