Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery (Decade)

Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Study Overview

• Status: Completed
• Conditions: Heart Disease
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Placebo

Detailed Description

The investigator goal is to evaluate the effects of intraoperative and postoperative dexmedetomidine sedation (versus placebo after cardiac surgery.

• Study Type: Interventional
• Enrollment (Actual): 798
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Dexmedetomidine; Dexmedetomidine
Placebo Comparator: Placebo; normal saline administration matching dexmedetomidine rate of infusion.	Drug: Placebo; Normal saline administration matching dexmedetomidine rate of infusion; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Atrial Arrhythmia	The occurrence of postoperative atrial arrhythmias	From the end of surgery to postoperative day 5
Number of Patients With Delirium	The occurrence of postoperative delirium	From the end of surgery to postoperative day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the end of surgery to postoperative day 5
Number of Patients With Incisional Pain	Patients were evaluated at 90 days by modified Brief Pain Inventory.	90 days after surgery

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Hospira, now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: Alparslan Turan, MD, Staff Member

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 18, 2020

Study Registration Dates

• First Submitted: August 1, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: March 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 12-1379