Inhaled Milrinone in Cardiac Surgery
The purpose of this study is to investigate the concentration-effect relationship of inhaled milrinone after prophylactic administration in cardiac surgical patients with preoperative pulmonary hypertension undergoing cardiopulmonary bypass.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients|
- Study the elimination rate of milrinone administered by inhalation [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
- Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone [ Time Frame: 15 min after the of study drug administration ] [ Designated as safety issue: Yes ]hemodynamic values evaluated will be: central venous pressure, systolic and diastolic pulmonary pressure, wedge, cardiac output, cardiac frequency, systolic and diastolic pressure, SaO2, EtCO2. Patient will also have arterial and venous gaz. Echographic values will be evaluated to see the cardiac fonction: left and right ventricular systolic and diastolic function and valvular function.
- Confirmation of the safety of inhaled milrinone [ Time Frame: 24 hours after cardiac surgery ] [ Designated as safety issue: Yes ]Verification of the absence of deleterious effects on cardiac output and systemic arterial pressure.
- Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension [ Time Frame: 15 min after end of milrinone administration ] [ Designated as safety issue: No ]Efficacy in the treatment of pulmonary hypertension is defined as a reduction of the mean pulmonary pressure of 10-20 %
|Study Start Date:||December 2006|
|Study Completion Date:||June 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: Inhaled milrinone 5 mg
Inhaled milrinone 5 mg(as for the injectable solution)
Drug: Inhaled milrinone 5 mg
Inhaled milrinone 5 mg (as for the injectable solution)
Other Name: Primacor
Milrinone elimination will be verify with blood and urine samples analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725776
|Montreal Heart Institute|
|Montreal, Quebec, Canada|
|Principal Investigator:||Andrée Denault, MD PhD FRCPC||Montreal Heart Institute|