Inhaled Milrinone in Cardiac Surgery

Pulmonary Hypertension Clinical Trial

Official title:

Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725776
• Other study ID #: ICM 06-888
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2012
• Last updated: November 8, 2012
• Start date: December 2006
• Est. completion date: June 2012

Study information

• Verified date: November 2012
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Inhaled milrinone 5 mg
Inhaled milrinone 5 mg (as for the injectable solution)

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Montreal Heart Institute	Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study the elimination rate of milrinone administered by inhalation		up to 24 hours	No
Secondary	Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone	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.	15 min after the of study drug administration	Yes
Secondary	Confirmation of the safety of inhaled milrinone	Verification of the absence of deleterious effects on cardiac output and systemic arterial pressure.	24 hours after cardiac surgery	Yes
Secondary	Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension	Efficacy in the treatment of pulmonary hypertension is defined as a reduction of the mean pulmonary pressure of 10-20 %	15 min after end of milrinone administration	No