The Delirium-CS Canada Study (DELIRIUM-CS)

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

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.

Study Overview

• Status: Completed
• Conditions: Delirium

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.

• Study Type: Observational
• Enrollment (Actual): 235

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre
    • Edmonton, Alberta, Canada, T6G 2B7
      • Mazankowski Alberta Heart Institute
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 4J8
      • St. Boniface General Hospital
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L4
      • New Brunswick Heart Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • QEII Health Sciences Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8L2X2
      • Hamilton General Hospital
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional Health Centre
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
    • Montreal, Quebec, Canada, H3A 1A1
      • Royal Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients undergoing cardiac surgery who are admitted to an ICU or CSRU following their procedure at twelve Canadian tertiary cardiac surgery centers in which patients are managed post-operatively in an intensive care unit (ICU) or cardiac surgery recovery unit (CSRU)

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: St. Boniface Hospital
• Collaborators: Hamilton Health Sciences Corporation; London Health Sciences Centre; Ottawa Heart Institute Research Corporation; Montreal Heart Institute; Royal Victoria Hospital, Canada; New Brunswick Heart Centre; Queen Elizabeth II Health Sciences Centre; Toronto General Hospital; Foothills Medical Centre; Southlake Regional Health Centre; Mazankowski Alberta Heart Institute
• Investigators: Principal Investigator: Rakesh C. Arora, MD, PhD, FRCSC, St. Boniface General Hospital - Cardiac Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: July 30, 2014
• First Submitted That Met QC Criteria: July 31, 2014
• First Posted (Estimate): August 1, 2014

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Cardiopulmonary Bypass; Thoracic Surgery; Intensive Care; Delirium
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: DELIRIUM CS-Canada