Recruiting

Cognitive Impairment

Sponsor:

University of Toronto

Code:

NCT02086877

Conditions

Critical Illness

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT02086877

Start date

Jan, 2014

Status verified date

Dec, 2016

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

ICU Survivors who required > 72 hrs mechanical ventilation

No intervention

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

Central Contacts and Locations

Central contacts

M. Elizabeth Wilcox, MD, MPH

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

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

St Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Orla Smith

osmith@smh.ca

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

University Health Network - Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

University Health Network - Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Paulina Farias

paulina.farias@uhn.ca

More Information

Sponsor

University of Toronto

Last update posted

Dec 15, 2016

Last verified

Dec, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2016-12-15.