Inhaled Milrinone in Cardiac Surgery

University of Montreal

Status and phase: Completed; Phase 2

Conditions: Pulmonary Hypertension

Treatments: Drug: Inhaled milrinone 5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01725776

ICM 06-888

Details and patient eligibility

About

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.

Full description

Milrinone elimination will be verify with blood and urine samples analysis.

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for elective cardiac surgery under CPB

• High risk patients: NYHA class II-III

• Preoperative diagnostic of pulmonary hypertension:

  • Systolic pulmonary artery pressure (sPAP) > 35 mm Hg; or
  • Mean pulmonary artery pressure (mPAP) > 25 mm Hg; or
  • mAP/mPAP < 3.0 (after induction of anesthesia).

Exclusion criteria

• Open Heart Surgery
• Contraindication to transesophageal echocardiography (TEE)
• Hemodynamic instability before surgery
• Emergency surgery

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Inhaled milrinone 5 mg

Experimental group

Description:

Inhaled milrinone 5 mg(as for the injectable solution)

Treatment:

Drug: Inhaled milrinone 5 mg