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Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery (Decade)

Primary Purpose

Heart Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Placebo
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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. 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.

Sites / Locations

  • Cleveland Clinic Main

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine

Placebo

Arm Description

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.

normal saline administration matching dexmedetomidine rate of infusion.

Outcomes

Primary Outcome Measures

Number of Patients With Atrial Arrhythmia
The occurrence of postoperative atrial arrhythmias
Number of Patients With Delirium
The occurrence of postoperative delirium

Secondary Outcome Measures

Number of Patients With Acute Kidney Injury
Acute kidney injury is defined according to Acute Kidney Injury Network (AKIN) classifications. No risk means no risk of acute kidney injury, while a higher stage means worse kidney function.
Number of Patients With Incisional Pain
Patients were evaluated at 90 days by modified Brief Pain Inventory.

Full Information

First Posted
August 1, 2013
Last Updated
March 12, 2021
Sponsor
The Cleveland Clinic
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02004613
Brief Title
Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
Acronym
Decade
Official Title
Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
798 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
normal saline administration matching dexmedetomidine rate of infusion.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Normal saline administration matching dexmedetomidine rate of infusion
Primary Outcome Measure Information:
Title
Number of Patients With Atrial Arrhythmia
Description
The occurrence of postoperative atrial arrhythmias
Time Frame
From the end of surgery to postoperative day 5
Title
Number of Patients With Delirium
Description
The occurrence of postoperative delirium
Time Frame
From the end of surgery to postoperative day 5
Secondary Outcome Measure Information:
Title
Number of Patients With Acute Kidney Injury
Description
Acute kidney injury is defined according to Acute Kidney Injury Network (AKIN) classifications. No risk means no risk of acute kidney injury, while a higher stage means worse kidney function.
Time Frame
From the end of surgery to postoperative day 5
Title
Number of Patients With Incisional Pain
Description
Patients were evaluated at 90 days by modified Brief Pain Inventory.
Time Frame
90 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-85 years old; Scheduled for cardiac surgery with bypass (CABG, valve, or combined); Able to provide a written informed consent; Hemodynamically stable (heart rate>= 55). Exclusion Criteria: Sick sinus syndrome or Wolff-Parkinson-White syndrome Atrio-ventricular block Hypersensitivity or known allergy to dexmedetomidine Hepatic disease, e.g. twice the normal level of liver enzymes Atrial fibrillation within 1 preoperative month; Permanent pacemaker; Use of amiodarone or dexmedetomidine within the last 30 days; Patients with an ejection fraction under 30% or who had severe heart failure Myocardial infarction in the previ¬ous 7 days; Body mass index =< 40 (BMI= mass (kg) / height (m)2); Those taking clonidine within last 48 hours.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alparslan Turan, MD
Organizational Affiliation
Staff member
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Main
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32682483
Citation
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.
Results Reference
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Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

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