HemodynamicsPhase 4NCT03855579
Levosimendan Versus Milrinone in Off Pump CABG Surgery
A Phase 4 study testing Levosimendan and Milrinone in people with Hemodynamics, run by Assiut University at 1 site in Egypt.
Trial summary
To compare the efficacy of Levosimendan versus Milrinone in supporting hemodynamics during off-pump coronary artery bypass grafting surgery in patients with low ejection fraction. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hemodynamics
- What is being tested?
- Levosimendan and Milrinone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Mar 2019to 10 Sep 2019
- Phase
- Phase 4
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective off-pump coronary artery bypass grafting surgery.
- ejection fraction < 50%
Who cannot join
- Patients with severe renal impairment or renal failure.
- Patients on mechanical support (intra-aortic balloon pump)
Trial locations and contacts
1 site in 1 country.
Fatma Mohamed, M.D. contact
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Hany M. Osman, M.D., +201002414591, hanymeo@gmail.com
Fatma N. Mohamed, M.D., +201003633992, fatmanabil2012@gmail.com
About this study
Official title: Levosimendan Versus Milrinone to Support Hemodynamics During Off Pump Coronary Artery Bypass Grafting Surgery in Patients With Poor Ejection Fraction
To compare the efficacy of Levosimendan versus Milrinone in supporting hemodynamics during off-pump coronary artery bypass grafting surgery in patients with low ejection fraction.
Read the detailed description
The major challenge during off-pump coronary artery bypass graft surgery is to maintain optimum hemodynamics by optimizing the intravascular volume and by using some inotropes. However, conventional inotropes such as beta-agonists are associated with tachycardia and arrhythmia which increase myocardial oxygen demand.
Levosimendan is an inodilator which exerts its positive inotropic effect by enhancing the sensitivity of troponin C to calcium without increasing intracellular calcium concentration. Levosimendan also decreases the systemic vascular resistance, so, it increases the cardiac output without increasing myocardial oxygen consumption.
This study aims to compare the efficacy of Levosimendan versus Milrinone in supporting hemodynamics during off-pump coronary artery bypass grafting surgery in patients with low ejection fraction.
- Conditions
- Hemodynamics
- Being tested
- Levosimendan, Milrinone
- Keywords
- Levosimendan, Milrinone, Off-pump, Coronary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
Intraoperative infusion of Levosimendan
MilrinoneDrug
Intraoperative infusion of Milrinone
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan | Experimental | Intraoperative infusion of Levosimendan Receives: Drug: Levosimendan |
| Milrinone | Active comparator | Intraoperative infusion of Milrinone Receives: Drug: Milrinone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean blood pressure
Measured: Intraoperative
Consumption of other inotropes
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start6 Mar 2019
- Primary completion10 Sep 2019 (estimated)
- Study completion10 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicsStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Mostafa Esmaeil Osman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855579
- Sponsor's protocol ID
- Levosimendan, Milrinone, CABG
- Status last verified
- Mar 2019
- First submitted
- 24 Feb 2019
- Last updated
- 7 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levosimendan Versus Milrinone to Support Hemodynamics During Off Pump Coronary Artery Bypass Grafting Surgery in Patients With Poor Ejection Fraction
- ClinicalTrials.gov ID
- NCT03855579
- Acronym / sponsor ID
- Levosimendan, Milrinone, CABG
- Conditions
- Hemodynamics
- Keywords
- Levosimendan, Milrinone, Off-pump, Coronary
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 10 Sep 2019 (estimated)
- Study completion
- 10 Sep 2019 (estimated)
- First posted
- 27 Feb 2019 (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.
To compare the efficacy of Levosimendan versus Milrinone in supporting hemodynamics during off-pump coronary artery bypass grafting surgery in patients with low ejection fraction.
Detailed description
The major challenge during off-pump coronary artery bypass graft surgery is to maintain optimum hemodynamics by optimizing the intravascular volume and by using some inotropes. However, conventional inotropes such as beta-agonists are associated with tachycardia and arrhythmia which increase myocardial oxygen demand.
Levosimendan is an inodilator which exerts its positive inotropic effect by enhancing the sensitivity of troponin C to calcium without increasing intracellular calcium concentration. Levosimendan also decreases the systemic vascular resistance, so, it increases the cardiac output without increasing myocardial oxygen consumption.
This study aims to compare the efficacy of Levosimendan versus Milrinone in supporting hemodynamics during off-pump coronary artery bypass grafting surgery in patients with low ejection fraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan | Experimental | Drug: LevosimendanIntraoperative infusion of Levosimendan |
| Milrinone | Active comparator | Drug: MilrinoneIntraoperative infusion of Milrinone |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective off-pump coronary artery bypass grafting surgery.
- ejection fraction < 50%
Key exclusion criteria (2 listed)
- Patients with severe renal impairment or renal failure.
- Patients on mechanical support (intra-aortic balloon pump)
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 |
|---|---|---|
| LevosimendanIntraoperative infusion of Levosimendan | Drug | Levosimendan |
| MilrinoneIntraoperative infusion of Milrinone | Drug | Milrinone |
Primary outcome
Mean blood pressure
Time frame: Intraoperative
Consumption of other inotropes
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
Fatma Mohamed, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levosimendan and Milrinone in people with Hemodynamics, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 2 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 7 Mar 2019. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hany M. Osman, M.D. (+201002414591 ext. N., hanymeo@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean blood pressure (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2019.