COGnitive Outcomes and WELLness in Survivors of Critical Illness
NCT ID: NCT02086877
Last Updated: 2016-12-15
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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UNKNOWN
150 participants
OBSERVATIONAL
2014-01-31
2018-12-31
Brief Summary
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Immediate opportunities to improve cognitive outcomes through risk reduction exist. The investigators propose to comprehensively study the prevalence of sleep abnormalities and their association with cognitive impairment, as it may yield potential targets for effective therapy. Moreover, the investigators will examine for gene x environment associations \[APOE ε4\] that may allow for genetic risk stratification of individuals at greatest risk of cognitive impairment. The investigators hypothesize that EEG \[a sensitive longitudinal marker of brain dysfunction\] is a novel and independent predictor of long-term cognitive impairment, and possibly a candidate intermediate end point for future clinical trials.
This study has the potential to identify novel biomarkers and risk factors for post-critical illness cognitive impairment, and may lay the foundation for rational interventions to mitigate risk in high-risk individuals.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ICU Survivors who required > 72 hrs mechanical ventilation
No intervention
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Admission to study ICU for invasive mechanical ventilation \[minimum of 72 hours\]
Exclusion Criteria
* Primary neurological injury \[e.g. anoxic brain injury, stroke or traumatic brain injury\]
* Anticipated death within 3 months of discharge \[e.g. palliative\]
* Uncontrolled psychiatric illness at hospital admission
* Not fluent in English
* Unlikely to adhere with follow-up \[e.g. no fixed address\]
* Residence greater than 300 kms from referral centre
16 Years
ALL
No
Sponsors
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The Physicians' Services Incorporated Foundation
OTHER
University of Toronto
OTHER
Responsible Party
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M. Elizabeth Wilcox
Dr. M. Elizabeth Wilcox
Principal Investigators
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M Elizabeth Wilcox
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor
Locations
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St Michael's Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Nicole Marinoff
Role: primary
Orla Smith
Role: primary
Sumesh Shah
Role: primary
Andrea Matte
Role: primary
Paulina Farias
Role: primary
References
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Wilcox ME, McAndrews MP, Van J, Jackson JC, Pinto R, Black SE, Lim AS, Friedrich JO, Rubenfeld GD. Sleep Fragmentation and Cognitive Trajectories After Critical Illness. Chest. 2021 Jan;159(1):366-381. doi: 10.1016/j.chest.2020.07.036. Epub 2020 Jul 24.
Wilcox ME, Lim AS, McAndrews MP, Wennberg RA, Pinto RL, Black SE, Walczak KD, Friedrich JO, Taglione MS, Rubenfeld GD. A study protocol for an observational cohort investigating COGnitive outcomes and WELLness in survivors of critical illness: the COGWELL study. BMJ Open. 2017 Jul 13;7(7):e015600. doi: 10.1136/bmjopen-2016-015600.
Other Identifiers
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13-6425-BE
Identifier Type: -
Identifier Source: org_study_id