Effect of Brief Nebulization of Milrinone on Pulmonary Arterial Pressure Before Cardiopulmonary Bypass on Mitral Valve Surgery Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tae-Yop Kim, MD PhD, Konkuk University Medical Center
ClinicalTrials.gov Identifier:
NCT01621971
First received: June 14, 2012
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

Our main hypothesis is that inhalation of milrinone can reduce the elevated pulmonary arterial pressure due to severe mitral valve regurgitation without compromising systemic hemodynamics. Therefore, the effects of a brief inhaled milrinone (IH) on pulmonary artery pressure are determined and compared to those of intravenous milrinone (IV) in severe mitral regurgitation patients undergoing mitral valve surgery.


Condition Intervention Phase
Pulmonary Hypertension
Mitral Regurgitation
Drug: inhaled milrinone
Drug: intravenous milrinone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Effects of Brief Inhaled Milrinone Versus Intravenous Milrinone on Pulmonary Arterial Pressure in Patients Undergoing Mitral Valve Surgery

Resource links provided by NLM:


Further study details as provided by Konkuk University Medical Center:

Primary Outcome Measures:
  • transpulmonary pressure gradient [ Time Frame: 10 min after milrinone administration ] [ Designated as safety issue: No ]
    transpulmonary pressure gradient (TPG= mean PAP-PAOP) before and 10 min after completely administering the study drug


Secondary Outcome Measures:
  • mean pulmonary arterial pressure [ Time Frame: 10 min after milrinone administration ] [ Designated as safety issue: No ]
    mean pulmonary artery pressure (MPAP) before and 10 min after completely administering the study drug

  • mean arterial pressure [ Time Frame: 10 min after milrinone administration ] [ Designated as safety issue: No ]
    mean arterial pressure(MAP) before and 10 min after completely administering the study drug

  • systemic vascular resistance [ Time Frame: 10 min after milrinone administration ] [ Designated as safety issue: No ]
    systemic vascular resistance (SVR) before and 10 min after completely administering the study drug

  • pulmonary vascular resistance [ Time Frame: 10 min after milrinone administration ] [ Designated as safety issue: No ]
    pulmonary vascular resistance (PVR) before and 10 min after completely administering the study drug


Enrollment: 20
Study Start Date: January 2003
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: milrinone inhalation
inhaled milirinone and IV placebo (0.9% normal saline 0.05 ml/kg) are administered in Group IH.
Drug: inhaled milrinone
After performing the sternotomy and achieving stable hemodynamics, but before the initiation of CPB, inhaled milirinone and intravenous placebo (0.9% normal saline 0.05 ml/kg) are administered
Other Name: Primacor, Sanofi-Synthelabo Canada Inc., Markham, ON, Canada
Active Comparator: intravenous milrinone
After performing the sternotomy and achieving stable hemodynamics, but before the initiation of CPB, inhaled placebo (distilled water) and an IV bolus of milrinone (50 μg/kg) are administered in Group IV
Drug: intravenous milrinone
After performing the sternotomy and achieving stable hemodynamics, but before the initiation of CPB, inhaled placebo (distilled water) and an intravenous bolus of milrinone (50 μg/kg) are administered
Other Name: Primacor, Sanofi-Synthelabo Canada Inc., Markham, ON, Canada

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing mitral valve surgery for chronic mitral regurgitation
  • estimated pulmonary hypertension (systolic PAP > 50 mmHg estimated by the velocity of tricuspid valve regurgitation in preoperative transthoracic echocardiography)
  • patients who agreed to participate in this study and signed written informed consent

Exclusion Criteria:

  • preoperative supraventricular tachycardia (SVT),
  • atrial fibrillation,
  • atrial flutter,
  • multiple ventricular ectopic contractions,
  • continuous inotropic support,
  • LV ejection fraction (EF) < 30%,
  • emergent surgery,
  • obstructive cardiomyopathy,
  • bronchial asthma
  • biochemical evidence of hepatic disease or renal impairment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621971

Locations
Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of, 143729
Sponsors and Collaborators
Konkuk University Medical Center
Investigators
Principal Investigator: Tae-Yop Kim, MD PhD Konkuk University Medical Center
  More Information

No publications provided

Responsible Party: Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT01621971     History of Changes
Other Study ID Numbers: KUH-MI201106
Study First Received: June 14, 2012
Last Updated: June 18, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Konkuk University Medical Center:
inhaled milrinone
pulmonary hypertension
mitral regurgitation
mitral valve surgery

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Mitral Valve Insufficiency
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Valve Diseases
Heart 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 July 22, 2014