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COGnitive Outcomes and WELLness in Survivors of Critical Illness

COGnitive Outcomes and WELLness in Survivors of Critical Illness

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02086877
Acronym
COGWELL
Enrollment
150
Registered
2014-03-13
Start date
2014-01-31
Completion date
2018-12-31
Last updated
2016-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Brief summary

As survival rates from critical illness improve, strategies to return patients to their baseline cognitive and functional status are important research priorities. Up to 100% of ICU survivors will suffer some degree of cognitive impairment at hospital discharge and approximately 50% will have decrements that persist for years. While the mechanisms for this newly acquired brain injury are poorly understood, several risk factors have been identified. Unfortunately, it is unclear how to accurately predict long-term cognitive impairment. 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.

Interventions

None listed

Sponsors

The Physicians' Services Incorporated Foundation
CollaboratorOTHER
University of Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ≥16 years of age * Admission to study ICU for invasive mechanical ventilation \[minimum of 72 hours\]

Exclusion criteria

* Advanced cognitive impairment or unable to follow simple commands before their acute illness \[e.g. end-stage Alzheimer's disease\] * 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

Design outcomes

Primary

MeasureTime frame
Change in cognitive performance from day 7 after ICU discharge as measured by the Repeatable Battery for the Assessment of Neuropsychological Status [RBANS] and Trail Making Tests A and B7 days, 6-months and 12-months after ICU discharge

Secondary

MeasureTime frame
Medical Outcomes Study Short Form -36 Questionnaire (SF-36)7 days, 6- and 12-months after ICU discharge
Beck Depression Inventory-II (BDI-II)7 days, 6- and 12-months after ICU discharge
Richard Campbell Sleep Questionnaire7 days, 6- and 12-months after ICU discharge
Pittsburgh Sleep Quality Index7 days, 6- and 12-months after ICU discharge

Countries

Canada

Contacts

Primary ContactM. Elizabeth Wilcox, MD, MPH
elizabeth.wilcox@utoronto.ca416-603-6203

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026