Delirium Clinical Trial
— DELIRIUM-CSOfficial title:
Examining DELIRIUM in Postoperative Cardiac Surgery Patient in Canada: Providing a National "Snapshot" of an Increasingly Devastating Complication
NCT number | NCT02206880 |
Other study ID # | DELIRIUM CS-Canada |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2014 |
Est. completion date | July 2018 |
Verified date | August 2018 |
Source | St. Boniface General Hospital Research Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Delirium is a prevalent complication following cardiac surgery that is under-recognized using
current methods of delirium detection and that may be better identified through a systematic
and standardized perioperative screening protocol.
The purpose of this study is to determine the incidence of postoperative delirium in the
current era of cardiac surgery using a validated delirium-screening tool.
Status | Completed |
Enrollment | 235 |
Est. completion date | July 2018 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All patients undergoing cardiac surgery who are admitted to an ICU or CSRU following their procedure Exclusion Criteria: - Patients in whom delirium cannot be reliably identified (e.g., previous debilitating stroke, cerebral palsy, severe dementia, severe hearing disabilities or inability to understand English or French, active seizure disorder or Child-Pugh class B or C cirrhosis) |
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Centre | Calgary | Alberta |
Canada | Mazankowski Alberta Heart Institute | Edmonton | Alberta |
Canada | QEII Health Sciences Centre | Halifax | Nova Scotia |
Canada | Hamilton General Hospital | Hamilton | Ontario |
Canada | London Health Sciences Centre | London | Ontario |
Canada | Montreal Heart Institute | Montreal | Quebec |
Canada | Royal Victoria Hospital | Montreal | Quebec |
Canada | Southlake Regional Health Centre | Newmarket | Ontario |
Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
Canada | New Brunswick Heart Centre | Saint John | New Brunswick |
Canada | Toronto General Hospital | Toronto | Ontario |
Canada | St. Boniface General Hospital | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
St. Boniface General Hospital Research Centre | Foothills Medical Centre, Hamilton Health Sciences Corporation, London Health Sciences Centre, Mazankowski Alberta Heart Institute, Montreal Heart Institute, New Brunswick Heart Centre, Ottawa Heart Institute Research Corporation, QEII Health Sciences Centre, Royal Victoria Hospital, Canada, Southlake Regional Health Centre, Toronto General Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Delirium following Cardiac Surgery | Each center will be allowed to employ the delirium-screening tool currently in use at their institution provided that the tool is either the Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). It is intended that either ICDSC or CAM-ICU, paired with a Richmond Agitation and Sedation Scale (RASS) or the Riker Sedation and Agitation Scale (SAS) be administered once per shift (i.e. with first assessment in the morning and a second assessment with the beginning of the evening shift). In addition, data regarding baseline demographic and clinical characteristics will be collected as well as data regarding the procedure performed (see Case Report Form (CRF). Patients will be considered as having had post-operative delirium if the results of at least one of the screening tests administered yielded a positive finding of delirium. | Delirium screening will be conducted for either up to 7 days following their date of surgery or up until their date of initial discharge from the intensive care unit, whichever comes first. |
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