COGnitive Outcomes and WELLness in Survivors of Critical Illness (COGWELL)

December 14, 2016 updated by: M. Elizabeth Wilcox, University of Toronto

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 1X5
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St Michael's Hospital
        • Contact:
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • University Health Network - Toronto General Hospital
        • Contact:
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • University Health Network - Toronto Western Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ICU Survivors who required > 72 hrs mechanical ventilation
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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 B
Time Frame: 7 days, 6-months and 12-months after ICU discharge
7 days, 6-months and 12-months after ICU discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Medical Outcomes Study Short Form -36 Questionnaire (SF-36)
Time Frame: 7 days, 6- and 12-months after ICU discharge
7 days, 6- and 12-months after ICU discharge
Beck Depression Inventory-II (BDI-II)
Time Frame: 7 days, 6- and 12-months after ICU discharge
7 days, 6- and 12-months after ICU discharge
Richard Campbell Sleep Questionnaire
Time Frame: 7 days, 6- and 12-months after ICU discharge
7 days, 6- and 12-months after ICU discharge
Pittsburgh Sleep Quality Index
Time Frame: 7 days, 6- and 12-months after ICU discharge
7 days, 6- and 12-months after ICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

The Physicians' Services Incorporated Foundation

Investigators

  • Principal Investigator: M Elizabeth Wilcox, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

December 15, 2016

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-6425-BE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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