Skip to main content
OpenTrials
Completed

NCT Number: NCT00819377

Milrinone Inhaled in Cardiac Surgery

Pulmonary hypertension is an important morbidity factor in patients having to undergo cardiac surgery with cardiopulmonary bypass (ECC). Milrinone used in inhalation, shows evidence of being a pulmonary vasodilator able to possibly contribute to the reduction of pressure on the pulmonary artery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Valvular Stenosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Hypertension Hypertension, Pulmonary Lung Diseases Myocardial Ischemia Respiratory Tract Diseases Valvular Insufficiency 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, H1T 1C8, Canada

About this study

This controlled, randomized, double-blind study will aim at confirming the efficiency as well as the security of Milrinone, used in inhalation, to diminish the degree of pulmonary hypertension before the cardiopulmonary bypass (ECC) circulation. In addition, the pharmacokinetic and echo graphic repercussions of administering the medication will be analysed. At the present time, there is no data on the pharmacokinetics of the medication when it's administered through inhalation. For this reason, we would like to study the serous rate of the medication in the minutes following its administration through inhalation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients scheduled for elective valvular or complex (2 or more valves or
  • valve and revascularization) cardiac surgery under CPB with preoperative PHT defined as mean pulmonary artery pressure (MPAP) over 30 mmHg or
  • systolic pulmonary artery pressure (SPAP) over 40 mmHg (using preoperative right-sided catheterization or estimated by echocardiography).

Exclusion criteria

  • Cardiac surgery not requiring CPB, contraindication to TEE (esophageal pathology or unstable cervical spine) and emergency surgery.
  • Patients will be recruited the day before surgery and randomized using computerized cards by the pharmacy department

Treatment and study plan

Milrinone

Drug

inhaled milrinone 5 mg (as for the injectable solution)

Other names: Milrinone Cardiac Surgery, Milrinone inhaled, Inhaled milrinone reduces pulmonary artery pressure

normal saline

Drug

5 ml normal saline by inhalation over 15 min

Other names: Placebo, Comparator

Primary outcomes

  1. To demonstrate that inhaled milrinone administered before CPB is superior to placebo in reducing the severity of difficult separation from bypass

    Time frame: End of CPB

Secondary outcomes

  1. Reduction in morbidity and mortality post-op

    Time frame: At discharge, 3 months, 6 months and 1 year by telephone

  2. Reduction in pulmonary artery pressure

    Time frame: Same day before and after CPB

  3. Right ventricular function measured using transthoracic echocardiography (TTE) and TEE

    Time frame: Same day before and after the CPB

  4. Serum levels of milrinone in relation with the pharmacodynamic marker

    Time frame: Same day pre CPB per CPB and post CPB

  5. reduction of the composite index of hemodynamic complications (defined as hospital death, vasoactive drugs > 24 hours and post-op cardiac arrest),

    Time frame: 24 hrs post op and hospital discharge

Sponsors and collaborators

Lead sponsor

Andre Denault

Other

Collaborators

  • Canadian Anesthesiologists' Society
  • Heart and stoke fondation of Quebec
  • Organon

Registry information

Official study title

2- Inhaled Milrinone Prevents the Increase in Pulmonary Artery Pressure After CPB

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 9, 2009
Registry last updated
Oct 25, 2013

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.