NCT04598191Unknown不适用
Effect of Intraoperative Iloprost Inhalant on Hemodynamic Stability in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: a Randomized, Blinded Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intraoperative cardiac index
研究概览
简要总结
Considering that the cause of hemodynamic instability during OPCAB is closely related to right ventricular dysfunction with pulmonary artery hypertension, the use of inhaled iloprost (a selective pulmonary vasodilator) in patients undergoing OPCAB maybe beneficial for hemodynamic management. Previous research has showed that inhaled iloprost reduce pulmonary arterial pressure and pulmonary vascular resistance. Therefore, by administering inhaled iloprost before the graft anastomosis might improve cardiac output, mixed venous blood oxygen saturation, and pulmonary oxygenation during the surgery especially during the graft anastomosis.
The objective of our study is to evaluate the effect of inhaled Iloprost on hemodynamic stability in patients undergoing off-pump coronary artery bypass graft surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 20 years and undergoing off-pump coronary artery bypass graft surgery with any of the following condition:
- •High risk of hemodynamically unstable (patient in NYHA functional class III-IV, or mean pulmonary-artery pressure ≥ 25 mm Hg or right ventricular systolic pressure ≥ 50mmHg in preoperative echo findings, preoperative left ventricular ejection fraction < 50%, acute myocardial infarction within 1 month of surgery, ventricular fibrillation)
- •History of previous cardiac operation (redo)
- •Left main coronary artery disease
- •Lesion at all three major coronary arteries
排除标准
- •Emergency operation
- •Patients undergoing minimally Invasive Direct Coronary Artery Bypass
- •Patients with cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
- •Patients with pre-existing infections prior to surgery (eg. sepsis)
- •Patients with liver cirrhosis
- •Patients with hemorrhagic disease / bleeding risk (history of active peptic ulcer, intracranial hemorrhage, congenital hemorrhagic disease etc.)
- •Patients with cerebrovascular event (TIA, stroke) within 3 months
- •Patients with symptomatic asthma/chronic obstructive pulmonary disease who are receiving treatment such as inhaler or steroid
- •Patient with severe chronic kidney disease (GFR(CKD-EPI) <30ml/min/1.73m2)
- •Patient with acute kidney injury
- •Patients who have participated in other clinical studies that may affect prognosis
- •Patients who cannot understand the informed consent (eg. Foreigner)
研究组 & 干预措施
Control group
Placebo Comparator
Participants in this group are administered inhaled normal saline.
干预措施: Control (Normal saline) (Drug)
iloprost group
Experimental
Participants in this group are administered inhaled iloprost.
干预措施: Iloprost (Drug)
结局指标
主要结局
Intraoperative cardiac index
时间窗: 5 minutes after pericardial closure
Compare the lowest intraoperative cardiac index between the Iloprost group and the control group during surgery, especially during the graft anastomosis.
次要结局
- central venous pressure(CVP in mmhg) for the intraoperative hemodynamic parameters(15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure)
- systemic arterial blood pressure for the intraoperative hemodynamic parameters(15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure)
- heart rate for the intraoperative hemodynamic parameters(15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure)
- pulmonary artery pressure for the intraoperative hemodynamic parameters(15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure)
- EKG rhythm for the intraoperative hemodynamic parameters(15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure)
- mixed venous oxygen saturation for the intraoperative hemodynamic parameters(15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure)
- PaO2/FiO2 ratio for the ventilation and oxygenation parameter(15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure)
- oxygen saturation in arterial blood for the ventilation and oxygenation parameter(15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure)
- dynamic compliance for the lung mechanics(15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure)
- arterial blood gas (ABG) test for oxygenation parameter(15 minutes after induction of anesthesia (baseline), 30 minutes after Iloprost administration, 5 minutes after pericardial closure)
- driving pressure for the lung mechanics(15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure)
- airway pressure (peak, plateau, PEEP) for the lung mechanics(15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure)
研究者
研究点 (1)
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