Cardiac SurgeryDEXCARDNCT04871308
Dexmedetomidine and Myocardial Protection
A study testing Dexmedetomidine in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Dexmedetomidine, an alpha-2 agonist, is a sedative that is widely used in various clinical settings because, compared to benzodiazepines, it preserves respiratory function better and its duration of action is short. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiac Surgery, Cardiopulmonary Bypass
- 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
- 224 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jul 2021to 7 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cardiac surgery utilizing cardiopulmonary bypass and aortic cross-clamp
Who cannot join
- Coronary artery bypass grafting
- Concomitant cryo-Maze procedure
- Myectomy
- Heart transplantation
- Concomitant major non-cardiac surgery
- Isolated complicated congenital heart surgery
Show all 15Show fewer
- descending thoracic aorta surgery with partial cardiopulmonary bypass
- Emergency surgery
- Minimally invasive or robot-assisted surgery
- Estimated GFR <30 ml/min/1.73 m2
- Documented end-stage renal disease
- Preoperative renal replacement therapy
- Preoperative history of percutaneous coronary intervention within 6 month before surgery
- Acute coronary syndrome within 4 weeks before surgery
- Preoperative mechanical circulatory support devices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardioprotective Effect of Dexmedetomidine in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: a Randomized, Placebo-controlled Trial
Dexmedetomidine, an alpha-2 agonist, is a sedative that is widely used in various clinical settings because, compared to benzodiazepines, it preserves respiratory function better and its duration of action is short.
Recent experimental studies showed a possibility that dexmedetomidine may have an organoprotective effect from ischemic-reperfusion injury by reducing inflammatory response. Besides, dexmedetomidine is known to be related with attenuated sympathetic tone and improved microcirculation.
Read more
Taken together, it is plausible that dexmedetomidine exerts cardioprotection in patients undergoing cardiac surgery with cardiopulmonary bypass and aortic cross-clamp.
The aim of this trial is to test the effect of dexmedetomidine on postoperative cardiac troponin I measurements in patients undergoing cardiac surgery.
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass
- Being tested
- Dexmedetomidine, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Anesthesia is induced using midazolam or etomidate, and sufentanil. A target-controlled infusion of propofol and remifentanil is used for anesthesia maintenance.
From anesthesia induction before the initiation of cardiopulmonary bypass, dexmedetomidine is infused intravenously at a rate of 0.5 mcg/kg/hr after a loading dose infusion of 0.75 mcg/kg for 10 mins.
ControlDrug
During the same time window for dexmedetomidine, normal saline is infused at the same rate calculated for dexmedetomidine.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo group using normal saline infusion Receives: Drug: Control |
| Dexmedetomidine | Active comparator | From anesthesia induction before the initiation of cardiopulmonary bypass, dexmedetomidine is infused intravenously at a rate of 0.5 mcg/kg/hr after a loading dose infusion of 0.75 mcg/kg for 10 mins. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac troponin I
Area under the curve of cardiac troponin I measured at 0, 6, 24, 48, 72 hours after surgery
Measured: Three days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start7 Jul 2021
- Primary completion30 Dec 2024
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karam Nam, MD, Seoul National University Hospital
- Investigators
- Karam Nam, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871308
- Sponsor's protocol ID
- DEXCARD
- Acronym
- DEXCARD
- Status last verified
- Jan 2026
- First submitted
- 3 May 2021
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioprotective Effect of Dexmedetomidine in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: a Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04871308
- Acronym / sponsor ID
- DEXCARD / DEXCARD
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dexmedetomidine, an alpha-2 agonist, is a sedative that is widely used in various clinical settings because, compared to benzodiazepines, it preserves respiratory function better and its duration of action is short.
Recent experimental studies showed a possibility that dexmedetomidine may have an organoprotective effect from ischemic-reperfusion injury by reducing inflammatory response. Besides, dexmedetomidine is known to be related with attenuated sympathetic tone and improved microcirculation.
Taken together, it is plausible that dexmedetomidine exerts cardioprotection in patients undergoing cardiac surgery with cardiopulmonary bypass and aortic cross-clamp.
The aim of this trial is to test the effect of dexmedetomidine on postoperative cardiac troponin I measurements in patients undergoing cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: ControlPlacebo group using normal saline infusion |
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineFrom anesthesia induction before the initiation of cardiopulmonary bypass, dexmedetomidine is infused intravenously at a rate of 0.5 mcg/kg/hr after a loading dose infusion of 0.75 mcg/kg for 10 mins. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- cardiac surgery utilizing cardiopulmonary bypass and aortic cross-clamp
Key exclusion criteria (15 listed)
- Coronary artery bypass grafting
- Concomitant cryo-Maze procedure
- Myectomy
- Heart transplantation
- Concomitant major non-cardiac surgery
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexAnesthesia is induced using midazolam or etomidate, and sufentanil. A target-controlled infusion of propofol and remifentanil is used for anesthesia maintenance. From anesthesia induction before the initiation of cardiopulmonary bypass, dexmedetomidine is infused intravenously at a rate of 0.5 mcg/kg/hr after a loading dose infusion of 0.75 mcg/kg for 10 mins. | Drug | Dexmedetomidine |
| ControlDuring the same time window for dexmedetomidine, normal saline is infused at the same rate calculated for dexmedetomidine. | Drug | Control |
Primary outcome
cardiac troponin I
Time frame: Three days after surgery
Area under the curve of cardiac troponin I measured at 0, 6, 24, 48, 72 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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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.
Karam Nam, M.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 15 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 30 Jan 2026. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
cardiac troponin I (time frame: Three days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2026; AzTrials last refreshed its copy on 2 Nov 2026.