COGnitive Outcomes and WELLness in Survivors of Critical Illness

Critical Illness Clinical Trial

— COGWELL  

Official title:

COGnitive Outcomes and WELLness in Survivors of Critical Illness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02086877
• Other study ID #: 13-6425-BE
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2014
• Last updated: December 14, 2016
• Start date: January 2014
• Est. completion date: December 2018

Study information

• Verified date: December 2016
• Source: University of Toronto
• Contact: M. Elizabeth Wilcox, MD, MPH
• Phone: 416-603-6203
• Email: elizabeth.wilcox[@]utoronto.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network - Toronto General Hospital	Toronto	Ontario
Canada	University Health Network - Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Medical Outcomes Study Short Form -36 Questionnaire (SF-36)		7 days, 6- and 12-months after ICU discharge	No
Secondary	Beck Depression Inventory-II (BDI-II)		7 days, 6- and 12-months after ICU discharge	No
Secondary	Richard Campbell Sleep Questionnaire		7 days, 6- and 12-months after ICU discharge	No
Secondary	Pittsburgh Sleep Quality Index		7 days, 6- and 12-months after ICU discharge	No