COGnitive Outcomes and WELLness in Survivors of Critical Illness (COGWELL)
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.
調査の概要
状態
条件
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
Ontario
-
Toronto、Ontario、カナダ、M4N 3M5
- 募集
- Sunnybrook Health Sciences Centre
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Toronto、Ontario、カナダ、M5G 1X5
- 募集
- Mount Sinai Hospital
-
コンタクト:
- Sumesh Shah
- メール:Sumesh.Shah@SinaiHealthSystem.ca
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Toronto、Ontario、カナダ、M5B 1W8
- 募集
- St Michael's Hospital
-
コンタクト:
- Orla Smith
- メール:osmith@smh.ca
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Toronto、Ontario、カナダ、M5G 2C4
- 募集
- University Health Network - Toronto General Hospital
-
コンタクト:
- Andrea Matte
- メール:andrea.matte@uhn.ca
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Toronto、Ontario、カナダ、M5T 2S8
- 募集
- University Health Network - Toronto Western Hospital
-
コンタクト:
- Paulina Farias
- メール:paulina.farias@uhn.ca
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
---|
ICU Survivors who required > 72 hrs mechanical ventilation
No intervention
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
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
時間枠:7 days, 6-months and 12-months after ICU discharge
|
7 days, 6-months and 12-months after ICU discharge
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Medical Outcomes Study Short Form -36 Questionnaire (SF-36)
時間枠:7 days, 6- and 12-months after ICU discharge
|
7 days, 6- and 12-months after ICU discharge
|
Beck Depression Inventory-II (BDI-II)
時間枠:7 days, 6- and 12-months after ICU discharge
|
7 days, 6- and 12-months after ICU discharge
|
Richard Campbell Sleep Questionnaire
時間枠:7 days, 6- and 12-months after ICU discharge
|
7 days, 6- and 12-months after ICU discharge
|
Pittsburgh Sleep Quality Index
時間枠:7 days, 6- and 12-months after ICU discharge
|
7 days, 6- and 12-months after ICU discharge
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:M Elizabeth Wilcox、Assistant Professor
出版物と役立つリンク
一般刊行物
- 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.
- Wilcox 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.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。