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

Yonsei University

Status: Unknown

Conditions: Coronary Artery Occlusive Disease

Treatments: Drug: Iloprost; Drug: Control (Normal saline)

Study type: Interventional

Funder types: Other

Identifiers

NCT04598191

4-2020-0907

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Participants in this group are administered inhaled normal saline.

Treatment:

Drug: Control (Normal saline)

iloprost group

Experimental group

Description:

Participants in this group are administered inhaled iloprost.

Treatment:

Drug: Iloprost