Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

NCT02004613

Last updated date
Study Location
Cleveland Clinic Main
Cleveland, Ohio, 44195, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Heart Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


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.

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Heart DiseaseAncillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
NCT02004613
  1. Cleveland, Ohio
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 * Turan A, Duncan A, Leung S, Karimi N, Fang J, Mao G, Hargrave J, Gillinov M, Trombetta C, Ayad S, Hassan M, Feider A, Howard-Quijano K, Ruetzler K, Sessler DI; DECADE Study Group. Dexmedetomidine for reduction of atrial fibrillation and delirium after cardiac surgery (DECADE): a randomised placebo-controlled trial. Lancet. 2020 Jul 18;396(10245):177-185. doi: 10.1016/S0140-6736(20)30631-0.

*   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, MDStaff 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