Text Size

Inhaled Milrinone in Cardiac Surgery

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Hospital St. Justine
Information provided by (Responsible Party):
Andre Denault, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT01725776
First received: June 18, 2012
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pulmonary Hypertension
 Drug: Inhaled milrinone 5 mg
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • Study the elimination rate of milrinone administered by inhalation [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone [ Time Frame: 15 min after the of study drug administration ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 24 hours after cardiac surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 15 min after end of milrinone administration ] [ Designated as safety issue: No ]
    Efficacy in the treatment of pulmonary hypertension is defined as a reduction of the mean pulmonary pressure of 10-20 %


Enrollment: 40
Study Start Date: December 2006
Study Completion Date: June 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled milrinone 5 mg
Inhaled milrinone 5 mg(as for the injectable solution)
 Drug: Inhaled milrinone 5 mg
Inhaled milrinone 5 mg (as for the injectable solution)
Other Name: Primacor

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725776

Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada
Sponsors and Collaborators
Montreal Heart Institute
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Hospital St. Justine
Investigators
Principal Investigator: Andrée Denault, MD PhD FRCPC Montreal Heart Institute
  More Information

No publications provided

Responsible Party: Andre Denault, MD PhD FRCPC ABIM-CCM, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT01725776     History of Changes
Other Study ID Numbers: ICM 06-888
Study First Received: June 18, 2012
Last Updated: November 8, 2012
Health Authority: Canada: Health Canada

Keywords provided by Montreal Heart Institute:
Pulmonary hypertension
Cardiac surgery
Cardiopulmonary Bypass (CPB)

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Milrinone
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013