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Completed

NCT Number: NCT01725776

Inhaled Milrinone in Cardiac Surgery

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Montreal Heart Institute

Montreal, Quebec, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhaled milrinone 5 mg

Drug

Inhaled milrinone 5 mg (as for the injectable solution)

Other names: Primacor

Primary outcomes

  1. Study the elimination rate of milrinone administered by inhalation

    Time frame: up to 24 hours

Secondary outcomes

  1. 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

    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.

  2. Confirmation of the safety of inhaled milrinone

    Time frame: 24 hours after cardiac surgery

    Verification of the absence of deleterious effects on cardiac output and systemic arterial pressure.

  3. Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension

    Time frame: 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 %

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Fonds de la Recherche en Santé du Québec
  • St. Justine's Hospital

Registry information

Official study title

Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Nov 14, 2012
Registry last updated
Nov 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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