Trial | NCT00819377  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    124
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.
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.
Study Started
Feb 28
2009
Primary Completion
Jan 31
2012
Study Completion
Dec 31
2012
Last Update
Oct 25
2013
Estimate

Drug Milrinone

inhaled milrinone 5 mg (as for the injectable solution)

  • Other names: Milrinone Cardiac Surgery, Milrinone inhaled, Inhaled milrinone reduces pulmonary artery pressure

Drug Normal saline

5 ml normal saline by inhalation over 15 min

  • Other names: Placebo, Comparator

Normal saline Placebo Comparator

Normal saline by inhalation over 15 min

Milrinone Active Comparator

Inhaled milrinone 5 mg(as for the injectable solution)

Criteria 

Inclusion Criteria:

Adult patients scheduled for elective valvular or complex (2 or more valves or
valve and revascularization) cardiac surgery under CPB with preoperative PHT defined as mean pulmonary artery pressure (MPAP) over 30 mmHg or
systolic pulmonary artery pressure (SPAP) over 40 mmHg (using preoperative right-sided catheterization or estimated by echocardiography).

Exclusion Criteria:

Cardiac surgery not requiring CPB, contraindication to TEE (esophageal pathology or unstable cervical spine) and emergency surgery.
Patients will be recruited the day before surgery and randomized using computerized cards by the pharmacy department
No Results Posted