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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Reclutamento
- Sunnybrook Health Sciences Centre
-
Toronto, Ontario, Canada, M5G 1X5
- Reclutamento
- Mount Sinai Hospital
-
Contatto:
- Sumesh Shah
- Email: Sumesh.Shah@SinaiHealthSystem.ca
-
Toronto, Ontario, Canada, M5B 1W8
- Reclutamento
- St Michael's Hospital
-
Contatto:
- Orla Smith
- Email: osmith@smh.ca
-
Toronto, Ontario, Canada, M5G 2C4
- Reclutamento
- University Health Network - Toronto General Hospital
-
Contatto:
- Andrea Matte
- Email: andrea.matte@uhn.ca
-
Toronto, Ontario, Canada, M5T 2S8
- Reclutamento
- University Health Network - Toronto Western Hospital
-
Contatto:
- Paulina Farias
- Email: paulina.farias@uhn.ca
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
ICU Survivors who required > 72 hrs mechanical ventilation
No intervention
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
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
Lasso di tempo: 7 days, 6-months and 12-months after ICU discharge
|
7 days, 6-months and 12-months after ICU discharge
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Medical Outcomes Study Short Form -36 Questionnaire (SF-36)
Lasso di tempo: 7 days, 6- and 12-months after ICU discharge
|
7 days, 6- and 12-months after ICU discharge
|
|
Beck Depression Inventory-II (BDI-II)
Lasso di tempo: 7 days, 6- and 12-months after ICU discharge
|
7 days, 6- and 12-months after ICU discharge
|
|
Richard Campbell Sleep Questionnaire
Lasso di tempo: 7 days, 6- and 12-months after ICU discharge
|
7 days, 6- and 12-months after ICU discharge
|
|
Pittsburgh Sleep Quality Index
Lasso di tempo: 7 days, 6- and 12-months after ICU discharge
|
7 days, 6- and 12-months after ICU discharge
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: M Elizabeth Wilcox, Assistant Professor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 13-6425-BE
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .