Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
235 participants
OBSERVATIONAL
2014-11-30
2018-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prevalence of Delirium in Patients Undergoing Cardiac Surgery
NCT00242151
INCIDENCE OF Delirium After Cardiac SURGERY Surgery
NCT04986488
Neuroinflammation and Postoperative Delirium in Cardiac Surgery
NCT02688179
Predictors for Postoperative Delirium After Cardiac Surgery in Adults: a One-year, Single Center, Observational Cohort Study
NCT02613845
Incidence, Severity and Treatment of Delirium in Cardiac Surgery Patients: A Before-after Study
NCT01774240
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
From September 1, 2014 to November 30, 2014, ALL patients undergoing cardiac surgery at each of the participating centers will be screened for post-operative delirium. Patients will NOT be excluded on the basis of urgency or procedure type. 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. 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. In addition to reporting an overall rate of delirium, unadjusted and adjusted incidence rates of delirium will be reported by institution and for the entire cohort. Risk-adjustment will be performed using multivariate regression modeling techniques.
This study will be the first to report on incidence rates of delirium following cardiac surgery across multiple centers employing standardized screening methodologies. The results of this study will provide valuable insight into the true burden of delirium among patients having undergone a cardiac surgical procedure in the current era. This is the first step in creating a multifaceted delirium prevention/treatment clinical pathway for the cardiac surgery patient.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Foothills Medical Centre
OTHER
Mazankowski Alberta Heart Institute
UNKNOWN
London Health Sciences Centre
OTHER
Southlake Regional Health Centre
OTHER
Toronto General Hospital
OTHER
Hamilton Health Sciences Corporation
OTHER
Ottawa Heart Institute Research Corporation
OTHER
Royal Victoria Hospital, Canada
OTHER
Montreal Heart Institute
OTHER
New Brunswick Heart Centre
OTHER
Queen Elizabeth II Health Sciences Centre
OTHER
St. Boniface Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Rakesh C. Arora
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rakesh C. Arora, MD, PhD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
St. Boniface General Hospital - Cardiac Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Foothills Medical Centre
Calgary, Alberta, Canada
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
New Brunswick Heart Centre
Saint John, New Brunswick, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
DELIRIUM-CS Investigators*; Canadian Cardiovascular Critical Care Society Investigator Group and the Canadian Critical Care Trials Group. Incidence of delirium after cardiac surgery: protocol for the DELIRIUM-CS Canada cross-sectional cohort study. CMAJ Open. 2017 Jul 13;5(3):E565-E569. doi: 10.9778/cmajo.20160136.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DELIRIUM CS-Canada
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.