Inhaled Milrinone in Cardiac Surgery
Information source: Montreal Heart Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Hypertension
Intervention: Inhaled milrinone 5 mg (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Montreal Heart Institute Official(s) and/or principal investigator(s): Andrée Denault, MD PhD FRCPC, Principal Investigator, Affiliation: Montreal Heart Institute
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.
Clinical Details
Official title: Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Study the elimination rate of milrinone administered by inhalation
Secondary outcome: Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinoneConfirmation of the safety of inhaled milrinone Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension
Detailed description:
Milrinone elimination will be verify with blood and urine samples analysis.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Montreal Heart Institute, Montreal, Quebec, Canada
Additional Information
Starting date: December 2006
Last updated: November 8, 2012
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