Back to resultsReducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care
Primary Purpose
Delirium, Cardiac Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Propofol
Dexmedetomidine
Sponsored by
About this trial
This is an interventional prevention trial for Delirium focused on measuring delirium, cardiac surgery, postoperative sedation
Eligibility Criteria
Inclusion Criteria:
- Age ≥60 years, undergoing high risk cardiac surgery, signed informed consent.
Exclusion Criteria:
- Patients with symptomatic cerebrovascular disease, history of delirium, schizophrenia or preoperative use of psychotropic medications.
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Propofol
Dexmedetomidine
Arm Description
Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation
Upon arrival to ICU patients will receive dexmedetomidine bolus of 0.4mcg/kg followed by an infusion of 0.2-0.7mcg/kg per hour for a maximum period of 24 hours.
Outcomes
Primary Outcome Measures
Dichotomous outcome, a number of patients with delirium in the two study groups.
Assessment of delirium will be performed utilizing the CAM-ICU
Secondary Outcome Measures
The total cost for each patient
Summation of direct-variable, direct-fixed, and overhead costs
Full Information
NCT ID
NCT01378741
First Posted
June 20, 2011
Last Updated
April 17, 2015
Sponsor
University Health Network, Toronto
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01378741
Brief Title
Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care
Official Title
Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to reduce the incidence of postoperative delirium after cardiac surgery in the elderly patient. This proposal is a clinical trial designed to reduce delirium in patients undergoing cardiac surgery by replacing standard postoperative sedation protocols (propofol, midazolam, opioids) with a new alpha2-adrenergic receptor agonist (dexmedetomidine) possessing sedative, analgesic, and antinociceptive properties. Resource utilization analysis will be performed to determine cost effectiveness of the new treatment modality.
Detailed Description
The proposed study will be a prospective, randomized, open label study comparing multimodal protocols for postoperative sedation after cardiac surgery. Patients will be randomly allocated to either dexmedetomidine or propofol (control) groups according to a computer generated randomization code in predetermined size blocks of four.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Cardiac Disease
Keywords
delirium, cardiac surgery, postoperative sedation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Upon arrival to ICU patients will receive dexmedetomidine bolus of 0.4mcg/kg followed by an infusion of 0.2-0.7mcg/kg per hour for a maximum period of 24 hours.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Upon arrival to ICU patients will receive dexmedetomidine bolus of 0.4mcg/kg followed by an infusion of 0.2-0.7mcg/kg per hour for a maximum period of 24 hours.
Primary Outcome Measure Information:
Title
Dichotomous outcome, a number of patients with delirium in the two study groups.
Description
Assessment of delirium will be performed utilizing the CAM-ICU
Time Frame
up to 7 days postoperatively or discharge
Secondary Outcome Measure Information:
Title
The total cost for each patient
Description
Summation of direct-variable, direct-fixed, and overhead costs
Time Frame
Up to 7 days or discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥60 years, undergoing high risk cardiac surgery, signed informed consent.
Exclusion Criteria:
Patients with symptomatic cerebrovascular disease, history of delirium, schizophrenia or preoperative use of psychotropic medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Djaiani, MD
Organizational Affiliation
Toronto General Hospital, UHN
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care
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