Effect of Intraoperative Iloprost Inhalant on Hemodynamic Stability in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery

Not Applicable

• Conditions: Coronary Artery Occlusive Disease
• Interventions: Drug: Control (Normal saline); Drug: Iloprost

• Registration Number: NCT04598191
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Status Verified: 2020-11
• Study Start: 2020-11-04
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control (Normal saline)	Participants in this group are administered inhaled normal saline.
iloprost group	Iloprost	Participants in this group are administered inhaled iloprost.

Primary Outcome Measures

Name	Time	Method
Intraoperative cardiac index	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yonsei Severance Hospital; 🇰🇷 Seoul, Korea, Republic of