Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
NCT02004613
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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).
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. Atrial fibrillation 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 taking clonidine within last 48 hours.
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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | Completed | |||
Actual Enrollment ICMJE | 798 | |||
Original Estimated Enrollment ICMJE | 965 | |||
Actual Study Completion Date ICMJE | December 18, 2020 | |||
Actual Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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PRS Account | The Cleveland Clinic | |||
Verification Date | March 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |