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The Delirium-CS Canada Study

Examining DELIRIUM in Postoperative Cardiac Surgery Patient in Canada: Providing a National Snapshot of an Increasingly Devastating Complication

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02206880
Acronym
DELIRIUM-CS
Enrollment
235
Registered
2014-08-01
Start date
2014-11-30
Completion date
2018-07-31
Last updated
2018-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

Thoracic Surgery, Delirium, Cardiopulmonary Bypass, Intensive Care

Brief summary

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.

Detailed description

Delirium is an acute confusional state characterized by fluctuating mental status, inattention, and either disorganized thinking or altered level of consciousness. It has long been recognized as a complication of cardiac surgery, a condition more likely to be experienced among elderly patients and those with greater comorbid disease burden. In recent years, increasing attention has been paid to the negative effect of delirium on post-operative outcomes, including long-term survival, freedom from hospital readmission and reduced cognitive and functional recovery. Despite this, little is still known about the true incidence of delirium following cardiac surgery, with published rates of delirium post-cardiac surgery ranging widely from 3% - 78%. 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.

Interventions

None listed

Sponsors

Foothills Medical Centre
CollaboratorOTHER
Mazankowski Alberta Heart Institute
CollaboratorUNKNOWN
London Health Sciences Centre
CollaboratorOTHER
Southlake Regional Health Centre
CollaboratorOTHER
Toronto General Hospital
CollaboratorOTHER
Hamilton Health Sciences Corporation
CollaboratorOTHER
Ottawa Heart Institute Research Corporation
CollaboratorOTHER
Royal Victoria Hospital, Canada
CollaboratorOTHER
Montreal Heart Institute
CollaboratorOTHER
New Brunswick Heart Centre
CollaboratorOTHER
Queen Elizabeth II Health Sciences Centre
CollaboratorOTHER
St. Boniface Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Delirium following Cardiac SurgeryDelirium 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026