Inhaled Milrinone in Cardiac Surgery

Phase 2

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: Inhaled milrinone 5 mg

• Registration Number: NCT01725776
• Lead Sponsor: Montreal Heart Institute

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2012-02
• Study Completion: 2012-06
• Study First Submitted: 2012-06-18
• Status Verified: 2012-11
• Study First Submitted QC: 2012-11-08
• Last Update Submitted: 2012-11-08
• Study First Posted: 2012-11-14
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inhaled milrinone 5 mg	Inhaled milrinone 5 mg	Inhaled milrinone 5 mg(as for the injectable solution)

Primary Outcome Measures

Name	Time	Method
Study the elimination rate of milrinone administered by inhalation	up to 24 hours

Secondary Outcome Measures

Name	Time	Method
Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone	15 min after the of study drug administration	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	24 hours after cardiac surgery	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	15 min after end of milrinone administration	Efficacy in the treatment of pulmonary hypertension is defined as a reduction of the mean pulmonary pressure of 10-20 %

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada