Coronary Artery Occlusive DiseaseNCT04598191
Effect of Intraoperative Iloprost Inhalant on Hemodynamic Stability in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery
A study testing Iloprost in people with Coronary Artery Occlusive Disease, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Occlusive Disease
- What is being tested?
- Iloprost
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Nov 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Severance Hospital
Seoul
Jae Kwang Shim, 82-2-2228-8516, ANESHIM@yuhs.ac
About this study
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
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
- Being tested
- Iloprost, Control (Normal saline)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloprostDrug
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)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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Participants in this group are administered inhaled normal saline. Receives: Drug: Control (Normal saline) |
| iloprost group | Experimental | Participants in this group are administered inhaled iloprost. Receives: Drug: Iloprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative cardiac index
Compare the lowest intraoperative cardiac index between the Iloprost group and the control group during surgery, especially during the graft anastomosis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 minutes after pericardial closure
Secondary outcomes (12)
systemic arterial blood pressure for the intraoperative hemodynamic parameters
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
mixed venous oxygen saturation for the intraoperative hemodynamic parameters
Measured: 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
PaO2/FiO2 ratio for the ventilation and oxygenation parameter
Measured: 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
oxygen saturation in arterial blood for the ventilation and oxygenation parameter
Measured: 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
arterial blood gas (ABG) test for oxygenation parameter
Measured: 15 minutes after induction of anesthesia (baseline), 30 minutes after Iloprost administration, 5 minutes after pericardial closure
airway pressure (peak, plateau, PEEP) for the lung mechanics
Measured: 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
dynamic compliance for the lung mechanics
Measured: 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
driving pressure for the lung mechanics
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start4 Nov 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jae Kwang Shim, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598191
- Sponsor's protocol ID
- 4-2020-0907
- Status last verified
- Nov 2020
- First submitted
- 12 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38148468
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04598191
- Acronym / sponsor ID
- 4-2020-0907
- Conditions
- Coronary Artery Occlusive Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Control (Normal saline)Participants in this group are administered inhaled normal saline. |
| iloprost group | Experimental | Drug: IloprostParticipants in this group are administered inhaled iloprost. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IloprostParticipants 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. | Drug | iloprost group |
| 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. | Drug | Control group |
Primary outcome
Intraoperative cardiac index
Time frame: 5 minutes before iloprost administration
Compare the lowest intraoperative cardiac index between the Iloprost group and the control group during surgery, especially during the graft anastomosis.
Intraoperative cardiac index
Time frame: 30 minutes after Iloprost administration
Compare the lowest intraoperative cardiac index between the Iloprost group and the control group during surgery, especially during the graft anastomosis.
Intraoperative cardiac index
Time frame: 5 minutes after the start of graft anastomosis
Compare the lowest intraoperative cardiac index between the Iloprost group and the control group during surgery, especially during the graft anastomosis.
Intraoperative cardiac index
Time frame: 5 minutes after pericardial closure
Compare the lowest intraoperative cardiac index between the Iloprost group and the control group during surgery, especially during the graft anastomosis.
12 secondary outcomes
systemic arterial blood pressure for the intraoperative hemodynamic parameters
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
mixed venous oxygen saturation for the intraoperative hemodynamic parameters
Time frame: 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
PaO2/FiO2 ratio for the ventilation and oxygenation parameter
Time frame: 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
oxygen saturation in arterial blood for the ventilation and oxygenation parameter
Time frame: 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
arterial blood gas (ABG) test for oxygenation parameter
Time frame: 15 minutes after induction of anesthesia (baseline), 30 minutes after Iloprost administration, 5 minutes after pericardial closure
airway pressure (peak, plateau, PEEP) for the lung mechanics
Time frame: 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
dynamic compliance for the lung mechanics
Time frame: 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
driving pressure for the lung mechanics
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Derived from this study: PubMed 38148468Ko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Kwang Shim principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iloprost in people with Coronary Artery Occlusive Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Kwang Shim (82-2-2228-8516, ANESHIM@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative cardiac index (time frame: 5 minutes before iloprost administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04598191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.