Heart DiseasePhase 4DecadeNCT02004613

Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

A Phase 4 study testing Dexmedetomidine in people with Heart Disease, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Heart Disease
What is being tested?: Dexmedetomidine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 798 participants
Where: 1 siteUnited States
Study dates: Jun 2013to 18 Dec 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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;

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic Main
Cleveland, Ohio, 44195

Other trials in United States

About this study

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.

Conditions: Heart Disease
Being tested: Dexmedetomidine, Placebo
Medical subject headings: Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmedetomidineDrug
Dexmedetomidine
PlaceboDrug
Also called Saline
Normal saline administration matching dexmedetomidine rate of infusion

Study groups in NCT02004613
Study group	Role	What they receive
Dexmedetomidine	Active comparator	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. Receives: Drug: Dexmedetomidine
Placebo	Placebo comparator	normal saline administration matching dexmedetomidine rate of infusion. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Atrial Arrhythmia
The occurrence of postoperative atrial arrhythmias
Measured: From the end of surgery to postoperative day 5
Number of Patients With Delirium
The occurrence of postoperative delirium
Measured: From the end of surgery to postoperative day 5

Secondary outcomes (2)

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.
Measured: 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.
Measured: 90 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201318 Dec 2020

First posted9 Dec 2013 (estimated)
Study startJun 2013
Primary completionDec 2018
Study completion18 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Heart DiseaseStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Investigator
Enrolment: 798 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02004613
Sponsor's protocol ID: 12-1379
Acronym: Decade
Status last verified: Mar 2021
First submitted: 1 Aug 2013
Last updated: 6 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Sari S, Brooker J, Montalvo-Campana M, Shehata P, Pu X, Insler S, Ruetzler K, Troianos CA, Turan A. The association of hemoglobin with postoperative delirium and atrial fibrillation after cardiac surgery: a retrospective sub-study. Braz J Anesthesiol. 2024 May-Jun;74(3):744424. doi: 10.1016/j.bjane.2023.02.003. Epub 2023 Mar 8.
PubMed 36894011
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
ClinicalTrials.gov ID: NCT02004613
Acronym / sponsor ID: Decade / 12-1379
Conditions: Heart Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 798 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Collaborators: Hospira, now a wholly owned subsidiary of Pfizer
Study start: Jun 2013 (actual)
Primary completion: Dec 2018 (actual)
Study completion: 18 Dec 2020 (actual)
First posted: 9 Dec 2013 (estimated)
Results: Posted 6 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Dexmedetomidine	Active comparator	Drug: DexmedetomidineDexmedetomidine 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.
Placebo	Placebo comparator	Drug: Placebonormal saline administration matching dexmedetomidine rate of infusion.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexmedetomidineDexmedetomidine	Drug	Dexmedetomidine
PlaceboAlso: SalineNormal saline administration matching dexmedetomidine rate of infusion	Drug	Placebo

Primary outcome

Number of Patients With Atrial Arrhythmia
Time frame: From the end of surgery to postoperative day 5
The occurrence of postoperative atrial arrhythmias
Number of Patients With Delirium
Time frame: From the end of surgery to postoperative day 5
The occurrence of postoperative delirium

2 secondary outcomes

Number of Patients With Acute Kidney Injury
Time frame: From the end of surgery to postoperative day 5
Number of Patients With Incisional Pain
Time frame: 90 days after surgery

Results and safety

Results posted to the registry on 6 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dexmedetomidine	400	398
Placebo	398	396

Primary outcome: Number of Patients With Atrial Arrhythmia

Time frame: From the end of surgery to postoperative day 5. Count of participants. Unit: Participants

Measure	Dexmedetomidine n = 397	Placebo n = 395
Value	121	134

Dexmedetomidine vs Placebo: Risk Ratio (RR): 0.91 (97.8% CI 0.72 to 1.15), p = 0.34, Regression, Logistic

Population analysed: 2 patients had no Atrial Arrhythmia data.

Primary outcome: Number of Patients With Delirium

Time frame: From the end of surgery to postoperative day 5. Count of participants. Unit: Participants

Measure	Dexmedetomidine n = 389	Placebo n = 387
Value	67	46

Dexmedetomidine vs Placebo: Risk Ratio (RR): 1.48 (97.8% CI 0.99 to 2.23), p = 0.026, Regression, Logistic

Population analysed: Delirium data is not available in 18 patients.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dexmedetomidine	21 of 394 (5.3%)	234 of 394 (59.4%)	1 of 394
Placebo	8 of 390 (2.1%)	154 of 390 (39.5%)	1 of 390

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36894011Sari S, Brooker J, Montalvo-Campana M, Shehata P, Pu X, Insler S, Ruetzler K, Troianos CA, Turan A. The association of hemoglobin with postoperative delirium and atrial fibrillation after cardiac surgery: a retrospective sub-study. Braz J Anesthesiol. 2024 May-Jun;74(3):744424. doi: 10.1016/j.bjane.2023.02.003. Epub 2023 Mar 8.
Derived from this study: PubMed 32682483Turan 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alparslan Turan, MD principal investigator

Staff member

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine in people with Heart Disease, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Atrial Arrhythmia (time frame: From the end of surgery to postoperative day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02004613, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.