Dexmedetomidine and Myocardial Protection

Cardiac Surgery Clinical Trial

— DEXCARD  

Official title:

Cardioprotective Effect of Dexmedetomidine in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: a Randomized, Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04871308
• Other study ID #: DEXCARD
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2021
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2024
• Source: Seoul National University Hospital
• Contact: Karam Nam, M.D.
• Phone: +82 2 2072 3108
• Email: karamnam[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: August 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• cardiac surgery utilizing cardiopulmonary bypass and aortic cross-clamp

Exclusion Criteria:

• Coronary artery bypass grafting
• Concomitant cryo-Maze procedure
• Myectomy
• Heart transplantation
• Concomitant major non-cardiac surgery
• Isolated complicated congenital heart surgery
• 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

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass

Intervention

Drug:
• Dexmedetomidine
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.
• Control
During the same time window for dexmedetomidine, normal saline is infused at the same rate calculated for dexmedetomidine.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac troponin I	Area under the curve of cardiac troponin I measured at 0, 6, 24, 48, 72 hours after surgery	Three days after surgery