NCT02206880

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

2.2 years

First QC Date

July 30, 2014

Last Update Submit

August 15, 2018

Conditions

Keywords

Thoracic SurgeryDeliriumCardiopulmonary BypassIntensive Care

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • All patients undergoing cardiac surgery who are admitted to an ICU or CSRU following their procedure

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Mazankowski Alberta Heart Institute

Edmonton, Alberta, T6G 2B7, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R3C 4J8, Canada

Location

New Brunswick Heart Centre

Saint John, New Brunswick, E2L 4L4, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Rakesh C. Arora, MD, PhD, FRCSC

    St. Boniface General Hospital - Cardiac Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 30, 2014

First Posted

August 1, 2014

Study Start

November 1, 2014

Primary Completion

January 1, 2017

Study Completion

July 1, 2018

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations