Critical IllnessCOGWELLNCT02086877
COGnitive Outcomes and WELLness in Survivors of Critical Illness
An observational study of Critical Illness, run by University of Toronto at 5 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 150 participants
- Where
- 5 sitesCanada
- Study dates
- Jan 2014to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill individuals who require mechanical ventilation for one week or greater
Who may be able to join
- ≥16 years of age
- Admission to study ICU for invasive mechanical ventilation [minimum of 72 hours]
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Nicole Marinoff, nicole.marinoff@sunnybrook.ca
- Recruiting
St Michael's Hospital
Toronto, Ontario, M5B 1W8
Orla Smith, osmith@smh.ca
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Sumesh Shah, Sumesh.Shah@SinaiHealthSystem.ca
- Recruiting
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4
Andrea Matte, andrea.matte@uhn.ca
- Recruiting
University Health Network - Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Paulina Farias, paulina.farias@uhn.ca
About this study
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
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU Survivors who required > 72 hrs mechanical ventilation | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days, 6-months and 12-months after ICU discharge
Secondary outcomes (4)
Medical Outcomes Study Short Form -36 Questionnaire (SF-36)
Measured: 7 days, 6- and 12-months after ICU discharge
Beck Depression Inventory-II (BDI-II)
Measured: 7 days, 6- and 12-months after ICU discharge
Richard Campbell Sleep Questionnaire
Measured: 7 days, 6- and 12-months after ICU discharge
Pittsburgh Sleep Quality Index
Measured: 7 days, 6- and 12-months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, M. Elizabeth Wilcox, University of Toronto
- Investigators
- M Elizabeth Wilcox, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086877
- Sponsor's protocol ID
- 13-6425-BE
- Acronym
- COGWELL
- Status last verified
- Dec 2016
- First submitted
- 7 Mar 2014
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32717265Wilcox 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.
PubMed 28710215
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COGnitive Outcomes and WELLness in Survivors of Critical Illness
- ClinicalTrials.gov ID
- NCT02086877
- Acronym / sponsor ID
- COGWELL / 13-6425-BE
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Survivors who required > 72 hrs mechanical ventilation | – | –No intervention |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill individuals who require mechanical ventilation for one week or greater
Key inclusion criteria (2 listed)
- ≥16 years of age
- Admission to study ICU for invasive mechanical ventilation [minimum of 72 hours]
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Medical Outcomes Study Short Form -36 Questionnaire (SF-36)
Time frame: 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
Richard Campbell Sleep Questionnaire
Time frame: 7 days, 6- and 12-months after ICU discharge
Pittsburgh Sleep Quality Index
Time frame: 7 days, 6- and 12-months after ICU discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
- Derived from this study: PubMed 32717265Wilcox 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.
- Derived from this study: PubMed 28710215Wilcox 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M Elizabeth Wilcox principal investigator
Assistant Professor
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by University of Toronto at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M. Elizabeth Wilcox, MD, MPH (416-603-6203, elizabeth.wilcox@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02086877, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016.