Efficacy of Dexamethasone to Reduce Inflammatory Response and Improve Clinical Outcome in Coronary Artery Bypass Patients: A Multi Arm, Double Blind, Single Center, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Perioperative myocardial infarction as seen on EKG
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary artery disease patients indicated for elective coronary artery bypass surgery
- •Patients aged >18 years old
- •Patients who agreed to participate in this study
排除标准
- •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
研究组 & 干预措施
Dexamethasone CCABG
Dexamethasone administered 1 mg per kg body weight (maximum dose 100 mg), given single dose after induction of anesthesia. Surgeon then carried out the conventional coronary artery bypass graft procedure with the use of cardiopulmonary bypass machine.
干预措施: Dexamethasone (Drug)
Placebo CCABG
Normal saline (NaCl 0.9%) administered 1 mg per kg body weight (maximum dose 100 mg), given single dose after induction of anesthesia. Surgeon then carried out the conventional coronary artery bypass graft procedure with the use of cardiopulmonary bypass machine.
干预措施: Normal saline (Drug)
Dexamethasone OPCAB
Dexamethasone administered 1 mg per kg body weight (maximum dose 100 mg), given single dose after induction of anesthesia. Surgeon then carried out the off-pump coronary artery bypass procedure without the use of cardiopulmonary bypass machine.
干预措施: Dexamethasone (Drug)
Placebo OPCAB
Normal saline (NaCl 0.9%) administered 1 mg per kg body weight (maximum dose 100 mg), given single dose after induction of anesthesia. Surgeon then carried out the off-pump coronary artery bypass procedure without the use of cardiopulmonary bypass machine.
干预措施: Normal saline (Drug)
结局指标
主要结局
Perioperative myocardial infarction as seen on EKG
时间窗: Daily during hospital stay (an average of 7 days)
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
时间窗: 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
时间窗: 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
Presence of arrhythmia as seen on EKG
时间窗: Daily during hospital stay (an average of 7 days)
New onset of a postoperative rhythm disorder including atrial fibrillation, ventricular tachycardia, ventricular fibrillation, supraventricular tachycardia, and atrioventricular block
次要结局
- Inflammatory reactions(18 to 24 hours post surgery)
研究者
Dudy Arman Hanafy, Sp. BTKV (K), MARS
Principal Investigator
Indonesia University