NCT00819377

Milrinone Inhaled in Cardiac Surgery

2- Inhaled Milrinone Prevents the Increase in Pulmonary Artery Pressure After CPB

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Andre Denault · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Pulmonary hypertension is an important morbidity factor in patients having to undergo cardiac surgery with cardiopulmonary bypass (ECC). Milrinone used in inhalation, shows evidence of being a pulmonary vasodilator able to possibly contribute to the reduction of pressure on the pulmonary artery.

Detailed description

This controlled, randomized, double-blind study will aim at confirming the efficiency as well as the security of Milrinone, used in inhalation, to diminish the degree of pulmonary hypertension before the cardiopulmonary bypass (ECC) circulation. In addition, the pharmacokinetic and echo graphic repercussions of administering the medication will be analysed. At the present time, there is no data on the pharmacokinetics of the medication when it's administered through inhalation. For this reason, we would like to study the serous rate of the medication in the minutes following its administration through inhalation.

Conditions

• Valvular Stenosis
• Valvular Insufficiency
• Hypertension, Pulmonary
• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Milrinone	inhaled milrinone 5 mg (as for the injectable solution)
DRUG	Normal saline	5 ml normal saline by inhalation over 15 min

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-01-01
• Completion: 2012-12-01
• First posted: 2009-01-09
• Last updated: 2013-10-25

Locations

1 site across 1 country: Canada