The Delirium-CS Canada Study

Delirium Clinical Trial

— DELIRIUM-CS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206880
• Other study ID #: DELIRIUM CS-Canada
• Status: Completed
• Start date: November 2014
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: St. Boniface General Hospital Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Delirium

Locations

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

Sponsors (12)

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

Country where clinical trial is conducted

Canada, 

Outcome

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.