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

NCT ID: NCT04598191

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-04

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Coronary Artery Occlusive Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.

Study Groups

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Control group

Participants in this group are administered inhaled normal saline.

Group Type PLACEBO_COMPARATOR

Control (Normal saline)

Intervention Type 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.

iloprost group

Participants in this group are administered inhaled iloprost.

Group Type EXPERIMENTAL

Iloprost

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jae Kwang Shim

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Yonsei Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae Kwang Shim

Role: CONTACT

[email protected]
82-2-2228-8516

Facility Contacts

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Jae Kwang Shim

Role: primary

[email protected]
82-2-2228-8516

References

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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.

Reference Type DERIVED
PMID: 38148468 (View on PubMed)

Other Identifiers

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4-2020-0907

Identifier Type: -

Identifier Source: org_study_id