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

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ClinicalTrials.gov Identifier: NCT02086877
Recruitment Status : Unknown
Verified December 2016 by M. Elizabeth Wilcox, University of Toronto.
Recruitment status was:  Recruiting
First Posted : March 13, 2014
Last Update Posted : December 15, 2016
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
M. Elizabeth Wilcox, University of Toronto

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.


Condition or disease
Critical Illness

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COGnitive Outcomes and WELLness in Survivors of Critical Illness
Study Start Date : January 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

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



Primary Outcome Measures :
  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 [ Time Frame: 7 days, 6-months and 12-months after ICU discharge ]

Secondary Outcome Measures :
  1. Medical Outcomes Study Short Form -36 Questionnaire (SF-36) [ Time Frame: 7 days, 6- and 12-months after ICU discharge ]
  2. Beck Depression Inventory-II (BDI-II) [ Time Frame: 7 days, 6- and 12-months after ICU discharge ]
  3. Richard Campbell Sleep Questionnaire [ Time Frame: 7 days, 6- and 12-months after ICU discharge ]
  4. Pittsburgh Sleep Quality Index [ Time Frame: 7 days, 6- and 12-months after ICU discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill individuals who require mechanical ventilation for one week or greater
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086877


Contacts
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Contact: M. Elizabeth Wilcox, MD, MPH 416-603-6203 elizabeth.wilcox@utoronto.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Nicole Marinoff       nicole.marinoff@sunnybrook.ca   
St Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Orla Smith       osmith@smh.ca   
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Sumesh Shah       Sumesh.Shah@SinaiHealthSystem.ca   
University Health Network - Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Andrea Matte       andrea.matte@uhn.ca   
University Health Network - Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Paulina Farias       paulina.farias@uhn.ca   
Sponsors and Collaborators
University of Toronto
The Physicians' Services Incorporated Foundation
Investigators
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Principal Investigator: M Elizabeth Wilcox Assistant Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M. Elizabeth Wilcox, Dr. M. Elizabeth Wilcox, University of Toronto
ClinicalTrials.gov Identifier: NCT02086877     History of Changes
Other Study ID Numbers: 13-6425-BE
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes