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

Coronary Artery Occlusive Disease Clinical Trial

Official title:

Effect of Intraoperative Iloprost Inhalant on Hemodynamic Stability in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: a Randomized, Blinded Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04598191
• Other study ID #: 4-2020-0907
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2020
• Est. completion date: December 2022

Study information

• Verified date: November 2020
• Source: Yonsei University
• Contact: Jae Kwang Shim
• Phone: 82-2-2228-8516
• Email: ANESHIM[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Occlusive Disease

Intervention

Drug:
• Iloprost
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.
• Control (Normal saline)
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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative cardiac index	Compare the lowest intraoperative cardiac index between the Iloprost group and the control group during surgery, especially during the graft anastomosis.	5 minutes before iloprost administration
Primary	Intraoperative cardiac index	Compare the lowest intraoperative cardiac index between the Iloprost group and the control group during surgery, especially during the graft anastomosis.	30 minutes after Iloprost administration
Primary	Intraoperative cardiac index	Compare the lowest intraoperative cardiac index between the Iloprost group and the control group during surgery, especially during the graft anastomosis.	5 minutes after the start of graft anastomosis
Primary	Intraoperative cardiac index	Compare the lowest intraoperative cardiac index between the Iloprost group and the control group during surgery, especially during the graft anastomosis.	5 minutes after pericardial closure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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