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

NCT01621971 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-06-19

No results posted yet for this study

Summary

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.

Conditions

  • Pulmonary Hypertension
  • Mitral Regurgitation

Interventions

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

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

Sponsors & Collaborators

  • Konkuk University Medical Center

    lead OTHER

Principal Investigators

  • Tae-Yop Kim, MD PhD · Konkuk University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2004-01-31
Completion
2004-01-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01621971 on ClinicalTrials.gov