Efficacy of Dexamethasone to Improve Clinical Outcomes in Coronary Artery Bypass Patients

• Status: Completed
• Trial end date: 2019-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center, double-blind, randomized controlled clinical trial comparing four groups: placebo conventional coronary artery bypass graft (CCABG) group, dexamethasone CCABG group, placebo off-pump coronary artery bypass (OPCAB) group, and dexamethasone OPCAB group. The primary outcomes of this study is comprised of presence of arrhythmia, major adverse cardiac events (MACE), myocardial infarction, stroke, renal failure, respiratory failure, inflammation, and death. These primary outcomes were assessed during the surgery, 18 hours post surgery, every day during the hospital stay, 14 days and 30 days post surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indonesia University
• Treatments: Dexamethasone

Criteria

Inclusion Criteria:

• Coronary artery disease patients indicated for elective coronary artery bypass surgery

• Patients aged >18 years old

• Patients who agreed to participate in this study

Exclusion Criteria:

• Patients with preoperative systemic inflammation evidenced by high axillary temperature (≥38◦C) and high leukocyte count (≥15.000 ul)

• Patients with chronic arrhythmia

• Patients who are indicated to undergo other procedures than coronary artery bypass (i.e. valvular repair, septal repair)

• Patients with history of severe organ dysfunction (class IV congestive heart failure, renal failure, respiratory arrest, and stroke with sequelae)

• Patients with history of cardiac surgery

• Patients who takes routine corticosteroids or immunomodulators

• Patients who are allergic to corticosteroids