COGnitive Outcomes and WELLness in Survivors of Critical Illness

NCT02086877 | Unknown DMC

• 1 other identifier: 13-6425-BE
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 5

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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

  7 days, 6-months and 12-months after ICU discharge

Secondary Outcomes (4)

• 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 Questionnaire

  7 days, 6- and 12-months after ICU discharge

• Pittsburgh Sleep Quality Index

  7 days, 6- and 12-months after ICU discharge

Study Arms (1)

ICU Survivors who required > 72 hrs mechanical ventilation

No intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill individuals who require mechanical ventilation for one week or greater

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (5)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

University Health Network - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 32717265 DERIVED

• 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.

  PMID: 28710215 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• M Elizabeth Wilcox

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M. Elizabeth Wilcox, MD, MPH

CONTACT

416-603-6203; elizabeth.wilcox@utoronto.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. M. Elizabeth Wilcox

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 13, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: December 15, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)