Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2
NCT ID: NCT03141619
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2017-10-13
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Respiratory failure and/or shock
All enrolled patients will undergo 72 hours of monitoring of cerebral oxygenation with near-infrared spectroscopy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Admitted to a critical care unit requiring one or more of the following:
(a) Respiratory failure requiring invasive mechanical ventilation with an expected duration \>24 hours (b) Shock of any etiology. Shock is defined by the need for one of the following vasopressors/inotropes: (i) Dopamine ≥7.5 mcg/kg/min (ii) Dobutamine ≥5 mcg/kg/min (iii) Norepinephrine ≥5 mcg/min (iv) Phenylephrine ≥75 mcg/min (v) Epinephrine at any dose (vi) Milrinone at any dose (if used in conjunction with another agent) (vii) Vasopressin ≥0.03 u/min(if used in conjunction with another agent)
Exclusion:
1. Admission to the ICU \> 24 hours
2. Life expectancy \<24 hours
3. Admitting diagnosis that affects the central nervous system
4. Any reason that the subject may not be able to participate in the follow up assessments (i.e. limb amputation, paresis, neuromuscular disorders)
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Vancouver General Hospital
OTHER
Western University, Canada
OTHER
University of Ottawa
OTHER
Université de Montréal
OTHER
University of Calgary
OTHER
University of Pittsburgh
OTHER
Dr. Gordon Boyd
OTHER
Responsible Party
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Dr. Gordon Boyd
Assistant Professor
Principal Investigators
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J. Gordon Boyd, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Queen's University
Locations
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Kingston General Hospital
Kingston, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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John G Boyd, MD, PhD
Role: primary
References
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Khan JM, Wood MD, Lee KFH, Maslove D, Muscedere J, English SW, Ball I, Slessarev M, Boyd JG. Delirium, Cerebral Perfusion, and High-Frequency Vital-Sign Monitoring in the Critically Ill. The CONFOCAL-2 Feasibility Study. Ann Am Thorac Soc. 2021 Jan;18(1):112-121. doi: 10.1513/AnnalsATS.202002-093OC.
Wood MD, Khan J, Lee KFH, Maslove DM, Muscedere J, Hunt M, Scott SH, Day A, Jacobson JA, Ball I, Slessarev M, O'Regan N, English SW, McCredie V, Chasse M, Griesdale D, Boyd JG. Assessing the relationship between near-infrared spectroscopy-derived regional cerebral oxygenation and neurological dysfunction in critically ill adults: a prospective observational multicentre protocol, on behalf of the Canadian Critical Care Trials Group. BMJ Open. 2019 Jun 25;9(6):e029189. doi: 10.1136/bmjopen-2019-029189.
Other Identifiers
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CTO Project ID 0815
Identifier Type: -
Identifier Source: org_study_id