Coronary Artery Occlusive Disease
Conditions
Brief summary
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.
Interventions
DRUGIloprost
Participants in Iloprost group will be administered aerosolized 20 μg iloprost in 15 min through a nebulizer connected to the inspiratory limb of the respiratory system when the internal mammary artery harvesting is done.
Participants in Control group will be administered aerosolized 5 ml of normal saline in 15 min through a nebulizer connected to the inspiratory limb of the respiratory system when the internal mammary artery harvesting is done.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.
Intervention model description
Patients are divided into 2 groups, who are administered aerosolized iloprost through a nebulizer connected to the inspiratory limb of the respiratory system, or who are administered same volume of normal saline at the same time and in the same manner.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative cardiac index | 5 minutes before iloprost administration | Compare the lowest intraoperative cardiac index between the Iloprost group and the control group during surgery, especially during the graft anastomosis. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
South Korea
Contacts
Primary ContactJae Kwang Shim
Outcome results
None listed