Inhaled Milrinone in Cardiac Surgery

Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01725776

Enrollment

Registered

2012-11-14

Start date

2006-12-31

Completion date

2012-06-30

Last updated

2012-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

Pulmonary hypertension, Cardiac surgery, Cardiopulmonary Bypass (CPB)

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.

Interventions

DRUGInhaled milrinone 5 mg

Inhaled milrinone 5 mg (as for the injectable solution)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
Study the elimination rate of milrinone administered by inhalation	up to 24 hours

Secondary

Measure	Time frame	Description
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 %

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026