Clinical trial NCT04598191: Effect of Intraoperative Iloprost Inhalant on Hemodynamic Stability in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Occlusive Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Intraoperative cardiac index
timeFrame: 5 minutes before iloprost administration
measure: Intraoperative cardiac index
timeFrame: 30 minutes after Iloprost administration
measure: Intraoperative cardiac index
timeFrame: 5 minutes after the start of graft anastomosis
measure: Intraoperative cardiac index
timeFrame: 5 minutes after pericardial closure
Secondary outcomes:
measure: systemic arterial blood pressure for the intraoperative hemodynamic parameters
timeFrame: 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
measure: central venous pressure(CVP in mmhg) for the intraoperative hemodynamic parameters
timeFrame: 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
measure: pulmonary artery pressure for the intraoperative hemodynamic parameters
timeFrame: 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
measure: heart rate for the intraoperative hemodynamic parameters
timeFrame: 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
measure: EKG rhythm for the intraoperative hemodynamic parameters
timeFrame: 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
measure: mixed venous oxygen saturation for the intraoperative hemodynamic parameters
timeFrame: 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
measure: PaO2/FiO2 ratio for the ventilation and oxygenation parameter
timeFrame: 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
measure: oxygen saturation in arterial blood for the ventilation and oxygenation parameter
timeFrame: 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
measure: arterial blood gas (ABG) test for oxygenation parameter
timeFrame: 15 minutes after induction of anesthesia (baseline), 30 minutes after Iloprost administration, 5 minutes after pericardial closure
measure: airway pressure (peak, plateau, PEEP) for the lung mechanics
timeFrame: 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
measure: dynamic compliance for the lung mechanics
timeFrame: 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
measure: driving pressure for the lung mechanics
timeFrame: 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
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Jae Kwang Shim
role: PRINCIPAL_INVESTIGATOR
References: