Efficacy of Dexamethasone to Improve Clinical Outcomes in Coronary Artery Bypass Patients
Condition: Coronary Artery Disease; Inflammatory Response
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      A single center randomized controlled clinical trial was conducted at Harapan Kita National
      Cardiovascular Center, Jakarta, Indonesia, as the tertiary cardiovascular referral hospital.
      The RCT was conducted from July 1st, 2018 to March 31st, 2019 (current status: completed).
      This study assessed the efficacy of intraoperative high dose dexamethasone administration (1
      mg/kg BW, maximum dose 100 mg) in reducing inflammatory response and improving clinical
      outcome in patients undergoing coronary artery bypass surgery. The study groups consist of
      placebo CCABG, dexamethasone CCABG, placebo OPCAB, and dexamethasone OPCAB. The subjects were
      adults indicated to undergo elective coronary artery bypass surgery with no evidence of prior
      inflammation nor allergic reaction to dexamethasone. Both the patients and the principal
      investigators were blinded for the treatment-control allocation. The patients were
      purposively selected and were randomly assigned to one of the arms with block randomization.
      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. The
      minimum sample size required for this study was 100 subjects (25 each group).
    

Intervention name(s): Dexamethasone; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Administration of intraoperative 1 mg/kg body weight dexamethasone; Placebo (NaCl 0.9%)
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blind, single center, multi-arm phase 4 randomized controlled clinical trial was conducted with four intervention arms: placebo CCABG, dexamethasone CCABG, placebo OPCAB, and dexamethasone OPCAB arm. The recruitment of subjects were conducted simultaneously by means of a block randomization.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dexamethasone; arrhythmia; atrial fibrillation; ventricular tachycardia; ventricular fibrillation