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Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery (Decade)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02004613
Recruitment Status : Active, not recruiting
First Posted : December 9, 2013
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Alparslan Turan, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE August 1, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date January 31, 2020
Actual Study Start Date  ICMJE June 2013
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
Sedation Outcome of patients assigned to dexmedetomidine or placebo. [ Time Frame: 3 to 90 Days after surgery ]
To measure whether dexmedetomidine sedation decreases the incidence of atrial arrhythmias.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
Sedation Outcome of patients assigned to dexmedetomidine or placebo [ Time Frame: 3 to 90 days after surgery ]
To measure whether dexmedetomidine sedation reduces postoperative delirium.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
Official Title  ICMJE Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
Brief Summary Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
Detailed Description The investigator goal is to evaluate the effects of intraoperative and postoperative dexmedetomidine sedation (versus placebo after cardiac surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Heart Disease
Intervention  ICMJE
  • Drug: Dexmedetomidine
    Dexmedetomidine
  • Drug: Placebo
    Normal saline administration matching dexmedetomidine rate of infusion
    Other Name: Saline
Study Arms  ICMJE
  • Active Comparator: Dexmedetomidine
    Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.
    Intervention: Drug: Dexmedetomidine
  • Placebo Comparator: Placebo
    normal saline administration matching dexmedetomidine rate of infusion.
    Intervention: Drug: Placebo
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2013)
965
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18-85 years old;
  2. Scheduled for cardiac surgery with bypass (CABG, valve, or combined);
  3. Able to provide a written informed consent;
  4. Hemodynamically stable (heart rate>= 55).

Exclusion Criteria:

  1. Sick sinus syndrome or Wolff-Parkinson-White syndrome
  2. Atrio-ventricular block
  3. Hypersensitivity or known allergy to dexmedetomidine
  4. Hepatic disease, e.g. twice the normal level of liver enzymes
  5. AF within 1 preoperative month;
  6. Permanent pacemaker;
  7. Use of amiodarone or dexmedetomidine within the last 30 days;
  8. Patients with an ejection fraction under 30% or who had severe heart failure
  9. Myocardial infarction in the previ¬ous 7 days;
  10. Body mass index =< 40 (BMI= mass (kg) / height (m)2);
  11. Those tak¬ing clonidine within last 48 hours.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02004613
Other Study ID Numbers  ICMJE 12-1379
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alparslan Turan, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Alparslan Turan, MD Staff member
PRS Account The Cleveland Clinic
Verification Date January 2020

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