Pulmonary Hypertension Due to Left Heart Disease
Conditions
Brief summary
The investigator compared difference between inhaled and intravenous milirinone in patiens with severe pulmonary hypertension undergoing cardiac surgery
Detailed description
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
Interventions
DRUGMilrinone inhalation
After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered
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
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean arterial pressure | 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) | The effect of inhaled milrinone on mean arterial pressure is compared with the effect of intravenous milrinone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| systemic vascular resistance | change in systemic vascular resistance 10 minutes after milrinone administration | The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone |
| mean pulmonary arterial pressure | change in mean pulmonary arterial pressure 10 minutes after milrinone administration | The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone |
| pulmonary vascular resistance | change in pulmonary vascular resistance 10 minutes after milrinone administration | The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone |
Countries
Egypt
Contacts
Primary ContactHeba M EL-Asser, MD
Backup ContactAmany S abdelazeem, MD
Outcome results
None listed