Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care

NCT01378741

Last updated date
Study Location
University Health Network
Toronto, Ontario, M5G 2C4, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Delirium, Cardiac Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age ≥60 years, undergoing high risk cardiac surgery, signed informed consent.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients with symptomatic cerebrovascular disease, history of delirium, schizophrenia
or preoperative use of psychotropic medications.

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Delirium, Cardiac DiseaseReducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care
NCT01378741
  1. Toronto, Ontario
ALL GENDERS
60 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care
Official Title  ICMJE Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Delirium
  • Cardiac Disease
Intervention  ICMJE
  • Drug: Propofol
    Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation
    Other Name: Diprivan
  • Drug: Dexmedetomidine
    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.
    Other Name: Precedex
Study Arms  ICMJE
  • Active Comparator: Propofol
    Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation
    Intervention: Drug: Propofol
  • Active Comparator: Dexmedetomidine
    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: Drug: Dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2015)
185
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2011)
200
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01378741
Other Study ID Numbers  ICMJE UHN10-0771A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:George Djaiani, MDToronto General Hospital, UHN
PRS Account University Health Network, Toronto
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP