Clinical trial NCT02086877: COGnitive Outcomes and WELLness in Survivors of Critical Illness
Official title: COGnitive Outcomes and WELLness in Survivors of Critical Illness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2014-03-13
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill individuals who require mechanical ventilation for one week or greater

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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 B
timeFrame: 7 days, 6-months and 12-months after ICU discharge
Secondary outcomes:
measure: Medical Outcomes Study Short Form -36 Questionnaire (SF-36)
timeFrame: 7 days, 6- and 12-months after ICU discharge
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 7 days, 6- and 12-months after ICU discharge
measure: Richard Campbell Sleep Questionnaire
timeFrame: 7 days, 6- and 12-months after ICU discharge
measure: Pittsburgh Sleep Quality Index
timeFrame: 7 days, 6- and 12-months after ICU discharge
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Assistant Professor
name: M Elizabeth Wilcox
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.