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The investigator compared difference between inhaled and intravenous milirinone in patiens with severe pulmonary hypertension undergoing cardiac surgery
Milrinone is widely used in cardiac surgery as an inotrope and pulmonary vasodilator agent But , intravenous milrinone has been associated with systemic hypotension and increased requirement for vasoactive drugs
The investigator compared difference between inhaled and intravenous milirinone in patiens with severe pulmonary hypertension undergoing cardiac surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group IH(inhaled milrinone) | Active Comparator | After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered |
|
| Group Iv(Intravenous milrinone) | Active Comparator | After induction of anesthesia and stable hemodynamics inhaled placebo( normal saline) is initiated and intravenous ( 1 mg/ml) (0.5 μg/kg/min)infusion are administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milrinone inhalation | Drug | After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered |
| Measure | Description | Time Frame |
|---|---|---|
| mean arterial pressure | The effect of inhaled milrinone on mean arterial pressure is compared with the effect of intravenous milrinone | change in mean arterial pressure is recorded 10 minutes after milrinone administration after induction (T1), at the end of nebulization (T2), before cardiopulmonary bypass (T3) and after cardiopulmonary bypass(T4) |
| Measure | Description | Time Frame |
|---|---|---|
| mean pulmonary arterial pressure | The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone | change in mean pulmonary arterial pressure 10 minutes after milrinone administration |
| systemic vascular resistance |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heba M EL-Asser, MD | Contact | 01062393152 | aseelaswad1@yahoo.com | |
| Amany S abdelazeem, MD | Contact | 01287220016 | dola.salah2009@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Heba M EL-Asser, MD | Zagazig University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University | Recruiting | Zagazig | Sharqia Province | 44519 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27470232 | Background | Denault AY, Bussieres JS, Arellano R, Finegan B, Gavra P, Haddad F, Nguyen AQN, Varin F, Fortier A, Levesque S, Shi Y, Elmi-Sarabi M, Tardif JC, Perrault LP, Lambert J. A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients. Can J Anaesth. 2016 Oct;63(10):1140-1153. doi: 10.1007/s12630-016-0709-8. Epub 2016 Jul 28. | |
| 19381522 |
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| ID | Term |
|---|---|
| D020105 | Milrinone |
| ID | Term |
|---|---|
| D000676 | Amrinone |
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 |
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A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.
|
| Milrinone infusion | Drug | After induction of anesthesia and stable hemodynamics inhaled placebo( normal saline) is initiated and intravenous ( 1 mg/ml) (0.5 μg/kg/min)infusion are administered |
|
|
The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone |
| change in systemic vascular resistance 10 minutes after milrinone administration |
| pulmonary vascular resistance | The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone | change in pulmonary vascular resistance 10 minutes after milrinone administration |
| Wang H, Gong M, Zhou B, Dai A. Comparison of inhaled and intravenous milrinone in patients with pulmonary hypertension undergoing mitral valve surgery. Adv Ther. 2009 Apr;26(4):462-8. doi: 10.1007/s12325-009-0019-4. Epub 2009 Apr 16. |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |