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CompletedNCT02004613DecadeUpdated Apr 6, 2021Results posted

Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

A Phase 4 interventional study of Dexmedetomidine and Placebo in Heart Disease, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-06.

Sponsored by The Cleveland Clinic · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
798
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
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Study summary

Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Read the detailed description

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

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Conditions studied

  • Heart Disease

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03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 798 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
798 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Placebo

    normal saline administration matching dexmedetomidine rate of infusion.

    Drug: Placebo

Interventions

  • DrugDexmedetomidine

    Dexmedetomidine

  • DrugPlacebo

    Normal saline administration matching dexmedetomidine rate of infusion

    Also known as: Saline

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What researchers measure

Primary outcomes

  1. Number of Patients With Atrial Arrhythmia

    The occurrence of postoperative atrial arrhythmias

    Time frame: From the end of surgery to postoperative day 5

  2. Number of Patients With Delirium

    The occurrence of postoperative delirium

    Time frame: From the end of surgery to postoperative day 5

Secondary outcomes

  1. 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.

    Time frame: From the end of surgery to postoperative day 5

  2. Number of Patients With Incisional Pain

    Patients were evaluated at 90 days by modified Brief Pain Inventory.

    Time frame: 90 days after surgery

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Results

Posted Apr 6, 2021

Participant flow

Participant flow — Overall Study
MilestoneDexmedetomidinePlacebo
Started400398
Completed398396
Not completed22

Outcome measures

PrimaryNumber of Patients With Atrial Arrhythmia

The occurrence of postoperative atrial arrhythmias

Time frame:
From the end of surgery to postoperative day 5
Reported as:
Count of participants · Participants
Number of Patients With Atrial Arrhythmia
ParticipantsDexmedetomidinePlacebo
Number of Patients With Atrial Arrhythmia121134
Statistical analysis
  • Dexmedetomidine vs Placebo · Regression, Logistic · p = 0.34 · Risk ratio (rr): 0.91 · 97.8% CI 0.72 to 1.15
PrimaryNumber of Patients With Delirium

The occurrence of postoperative delirium

Time frame:
From the end of surgery to postoperative day 5
Reported as:
Count of participants · Participants
Number of Patients With Delirium
ParticipantsDexmedetomidinePlacebo
Number of Patients With Delirium6746
Statistical analysis
  • Dexmedetomidine vs Placebo · Regression, Logistic · p = 0.026 · Risk ratio (rr): 1.48 · 97.8% CI 0.99 to 2.23
SecondaryNumber 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.

Time frame:
From the end of surgery to postoperative day 5
Reported as:
Count of participants · Participants
Number of Patients With Acute Kidney Injury
ParticipantsDexmedetomidinePlacebo
No risk348359
stage13329
Stage240
Stage341
Statistical analysis
  • Dexmedetomidine vs Placebo · Regression, Logistic · p = 0.14 · Risk ratio (rr): 1.40 · 97.5% CI 0.84 to 2.34
SecondaryNumber of Patients With Incisional Pain

Patients were evaluated at 90 days by modified Brief Pain Inventory.

Time frame:
90 days after surgery
Reported as:
Count of participants · Participants
Number of Patients With Incisional Pain
ParticipantsDexmedetomidinePlacebo
Number of Patients With Incisional Pain7993
Statistical analysis
  • Dexmedetomidine vs Placebo · Regression, Logistic · p = 0.29 · Risk ratio (rr): 0.87 · 97.5% CI 0.65 to 1.16

Adverse events

Collected over 5 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dexmedetomidine1/394 (0.3%)21/394 (5.3%)234/394 (59.4%)
Placebo1/390 (0.3%)8/390 (2.1%)154/390 (39.5%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventDexmedetomidinePlacebo
HemorrhageBlood and lymphatic system disorders4/3943/390
strokeNervous system disorders3/3941/390
infectionInfections and infestations2/3940/390
AtelectasisRespiratory, thoracic and mediastinal disorders2/3940/390
asystolCardiac disorders1/3941/390
re-interventionCardiac disorders0/3941/390
seizureNervous system disorders0/3941/390
PneumothoraxRespiratory, thoracic and mediastinal disorders1/3941/390
heart failureCardiac disorders1/3940/390
HypoxemiaRespiratory, thoracic and mediastinal disorders1/3940/390
Most frequent other events
Most frequent other events
EventDexmedetomidinePlacebo
Clinically important hypotensionBlood and lymphatic system disorders224/394140/390
Clinically important bradycardiaCardiac disorders36/39445/390

Baseline characteristics

Age, Continuous
Age, Continuous(years)DexmedetomidinePlaceboTotal
Mean63 ± 1162 ± 1263 ± 12
Sex: Female, Male
Sex: Female, Male(Participants)DexmedetomidinePlaceboTotal
Female132111243
Male264283547
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)DexmedetomidinePlaceboTotal
Race — white365363728
Race — not white303161
Region of Enrollment
Region of Enrollment(participants)DexmedetomidinePlaceboTotal
United States398396794
Modified Brief Pain Inventory
Modified Brief Pain Inventory(Participants)DexmedetomidinePlaceboTotal
Overall Severity (any)9589184
Pain interference (any)8583168
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Study locations

1 site
  • Cleveland Clinic Main
    Cleveland, Ohio 44195, United States
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References and documents

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. PubMed 32682483 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 12, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02004613
Lead sponsor
The Cleveland Clinic
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
Responsible party
Alparslan Turan (Staff, The Cleveland Clinic) — Principal investigator
First posted
Dec 9, 2013
Start date
Jun 2013
Primary completion
Dec 2018
Completion
Dec 18, 2020
Results posted
Apr 6, 2021
Last update
Apr 6, 2021

Study contacts

Alparslan Turan, MD
principal investigator · Staff member

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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