Coronary Artery Disease, Inflammatory Response
Conditions
Keywords
dexamethasone, arrhythmia, atrial fibrillation, ventricular tachycardia, ventricular fibrillation
Brief 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).
Interventions
DRUGDexamethasone
Administration of intraoperative 1 mg/kg body weight dexamethasone
DRUGNormal saline
Placebo (NaCl 0.9%)
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator) Participants were not aware of the arms/treatment given as they were under general anesthesia during the administration of dexamethasone. Preoperatively, subjects were given explanation of the purpose, methods, benefits, and risks of the procedure including the randomization method. Investigators were kept unaware of the randomization of dexamethasone as they were restricted for assessing the patients' medical record and the patients' identity were coded in the primary database
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of arrhythmia as seen on EKG | 18 to 24 hours post surgery | New onset of a postoperative rhythm disorder including atrial fibrillation, ventricular tachycardia, ventricular fibrillation, supraventricular tachycardia, and atrioventricular block |
| Perioperative myocardial infarction as seen on EKG | 18 to 24 hours post surgery | New Q waves or new left bundle branch block on an electrocardiogram, combined with a biomarker (creatine kinase-MB or troponin) \>5 times the upper normal limit |
| Presence of stroke diagnosed by clinical appearance and CT or MRI | Daily during hospital stay (an average of 7 days) | A neurologic deficit lasting more than 24 hours with signs of a new ischemic cerebral infarction on computed tomography or magnetic resonance imaging |
| Renal failure as measured by serum creatinine | 18 to 24 hours post surgery | Increase in postoperative serum creatinine of at least 3-times the preoperative value, or a serum creatinine level \>4mg/dL associated with an acute increase in serum creatinine of at leas 0.5mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory reactions | 18 to 24 hours post surgery | Measurement of interleukin (IL)-6, C-reactive protein (CRP), and procalcitonin |
Countries
Indonesia
Outcome results
None listed