Comparing inhaled and intravenous milrinone for severe pulmonary hypertension during heart surgery
Comparative Study Between Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension Undergoing Cardiac Surgery
This study is testing whether giving milrinone through inhalation or an IV is better and safer for patients with severe pulmonary hypertension during heart surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig, Sharqia Province) |
| Trial ID | NCT04484675 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of inhaled versus intravenous milrinone in patients with severe pulmonary hypertension who are scheduled for cardiac surgery. Milrinone is commonly used as an inotropic agent and pulmonary vasodilator, but intravenous administration can lead to systemic hypotension and increased need for other vasoactive medications. By comparing these two methods of administration, the study aims to determine which approach is more effective and safer for patients undergoing mitral valve surgery. The study will involve patients with a specific mean pulmonary artery pressure as assessed by preoperative echocardiography.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for mitral valve surgery with a mean pulmonary artery pressure of 55 mmHg or higher.
Not a fit: Patients who may not benefit include those with severe left ventricular dysfunction, hemodynamic instability, or contraindications to the study interventions.
Why it matters
Potential benefit: If successful, this study could lead to improved management of pulmonary hypertension in patients undergoing cardiac surgery, potentially reducing complications and improving outcomes.
How similar studies have performed: While the use of milrinone is established, this specific comparison of inhaled versus intravenous administration in this patient population is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled to undergo mitral valve surgery by cardiopulmonary bypass with estimated mean pulmonary artery pressure =\>55 estimated by using preoperative Doppler echocardiography Exclusion Criteria: Patients were excluded if they had surgery without CPB, preoperative hemodynamic instability (defined as acute requirement for vasoactive support or mechanical device),Patients with severe LV dysfunction (LV ejection fraction of less than 30% congenital heart disease, a contraindication to transesophageal echocardiography (TEE), emergency surgery or re-do surgeries severe renal or hepatic disease , coagulopathy, and thromboembolic disease treated with anticoagulants
Where this trial is running
Zagazig, Sharqia Province
- Zagazig University — Zagazig, Sharqia Province, Egypt (Recruiting)
Study contacts
- Principal investigator: Heba M EL-Asser, MD — Zagazig University
- Study coordinator: Heba M EL-Asser, MD
- Email: aseelaswad1@yahoo.com
- Phone: 01062393152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.