DeliriumDELIRIUM-CSNCT02206880
The Delirium-CS Canada Study
An observational study of Delirium, run by St. Boniface Hospital at 12 sites in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Delirium
- How many people
- 235 participants
- Where
- 12 sitesCanada
- Study dates
- Nov 2014to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- All patients undergoing cardiac surgery who are admitted to an ICU or CSRU following their procedure
Who cannot join
- 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)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Mazankowski Alberta Heart Institute
Edmonton, Alberta, T6G 2B7
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Hamilton General Hospital
Hamilton, Ontario, L8L2X2
London Health Sciences Centre
London, Ontario, N6A 5A5
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
New Brunswick Heart Centre
Saint John, New Brunswick, E2L 4L4
Toronto General Hospital
Toronto, Ontario, M5G 2C4
St. Boniface General Hospital
Winnipeg, Manitoba, R3C 4J8
About this study
Official title: 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.
Read the 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.
- Conditions
- Delirium
- Keywords
- Thoracic Surgery, Delirium, Cardiopulmonary Bypass, Intensive Care
- Medical subject headings
- Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Foothills Medical Centre, Mazankowski Alberta Heart Institute, London Health Sciences Centre, Southlake Health, Toronto General Hospital, Hamilton Health Sciences Corporation, Ottawa Heart Institute Research Corporation, Royal Victoria Hospital, Canada, Montreal Heart Institute, New Brunswick Heart Centre, Queen Elizabeth II Health Sciences Centre
- Responsible party
- Principal investigator, Dr. Rakesh C. Arora, St. Boniface Hospital
- Investigators
- Rakesh C. Arora, MD, PhD, FRCSC, Principal investigator, St. Boniface General Hospital - Cardiac Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206880
- Sponsor's protocol ID
- DELIRIUM CS-Canada
- Acronym
- DELIRIUM-CS
- Status last verified
- Aug 2018
- First submitted
- 30 Jul 2014
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28743102
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining DELIRIUM in Postoperative Cardiac Surgery Patient in Canada: Providing a National "Snapshot" of an Increasingly Devastating Complication
- ClinicalTrials.gov ID
- NCT02206880
- Acronym / sponsor ID
- DELIRIUM-CS / DELIRIUM CS-Canada
- Conditions
- Delirium
- Keywords
- Thoracic Surgery, Delirium, Cardiopulmonary Bypass, Intensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Collaborators
- Foothills Medical Centre, Mazankowski Alberta Heart Institute, London Health Sciences Centre, Southlake Health, Toronto General Hospital, Hamilton Health Sciences Corporation, Ottawa Heart Institute Research Corporation, Royal Victoria Hospital, Canada, Montreal Heart Institute, New Brunswick Heart Centre, Queen Elizabeth II Health Sciences Centre
- Study start
- Nov 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- All patients undergoing cardiac surgery who are admitted to an ICU or CSRU following their procedure
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Delirium following Cardiac Surgery
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Derived from this study: PubMed 28743102DELIRIUM-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.
Related trials for Delirium
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Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakesh C. Arora, MD, PhD, FRCSC principal investigator
St. Boniface General Hospital - Cardiac Sciences
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by St. Boniface Hospital at 12 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Delirium following Cardiac Surgery (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02206880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.