Milrinone Inhaled in Cardiac Surgery

Andre Denault

Status and phase: Completed; Phase 2

Conditions: Valvular Stenosis; Coronary Artery Disease; Hypertension, Pulmonary; Valvular Insufficiency

Treatments: Drug: Normal saline; Drug: Milrinone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00819377

08-1004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups, including a placebo group

Normal saline

Placebo Comparator group

Description:

Normal saline by inhalation over 15 min

Treatment:

Drug: Normal saline

Milrinone

Active Comparator group

Description:

Inhaled milrinone 5 mg(as for the injectable solution)

Treatment:

Drug: Milrinone