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

NCT04598191 | Unknown

• 1 other identifier: 4-2020-0907
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Occlusive Disease

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (12)

• 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

• 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

Study Arms (2)

Control group

PLACEBO COMPARATOR

Participants in this group are administered inhaled normal saline.

Drug: Control (Normal saline)

iloprost group

EXPERIMENTAL

Participants in this group are administered inhaled iloprost.

Drug: Iloprost

Interventions

Iloprost DRUG

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.

iloprost group

Control (Normal saline) DRUG

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.

Control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Severance Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• Ko SH, Shim JK, Song JW, Soh S, Kwak YL. Inhaled iloprost in off-pump coronary artery bypass surgery: a randomized controlled trial. Can J Anaesth. 2024 Apr;71(4):479-489. doi: 10.1007/s12630-023-02672-3. Epub 2023 Dec 26.

  PMID: 38148468 DERIVED

MeSH Terms

Interventions

Iloprost; Saline Solution

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jae Kwang Shim

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae Kwang Shim

CONTACT

82-2-2228-8516; ANESHIM@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 22, 2020
• Study Start: November 4, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)