Milrinone Inhaled in Cardiac Surgery

This study has been completed.
Sponsor:
Collaborators:
Heart and stoke fondation of Quebec
Organon
Canadian Anesthesiologists' Society
Information provided by (Responsible Party):
Andre Denault, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT00819377
First received: January 8, 2009
Last updated: October 23, 2013
Last verified: October 2013

January 8, 2009
October 23, 2013
February 2009
January 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
20% reduction in the proportion of patients classified as having a severe DSB (Difficult Seperation from Bypass) score in the active treatment arm compared to placebo. [ Time Frame: after CPB ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00819377 on ClinicalTrials.gov Archive Site
  • Reduction in morbidity and mortality post-op [ Time Frame: At discharge, 3 months, 6 months and 1 year by telephone ] [ Designated as safety issue: Yes ]
  • Reduction in pulmonary artery pressure [ Time Frame: Same day before and after CPB ] [ Designated as safety issue: Yes ]
  • Right ventricular function measured using transthoracic echocardiography (TTE) and TEE [ Time Frame: Same day before and after the CPB ] [ Designated as safety issue: Yes ]
  • Serum levels of milrinone in relation with the pharmacodynamic marker [ Time Frame: Same day pre CPB per CPB and post CPB ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Reduction in morbidity and mortality post-op [ Time Frame: Discharge and 3 months, 6 month and 1 years by call ] [ Designated as safety issue: Yes ]
  • Reduction in pulmonary artery pressure [ Time Frame: before and after CPB ] [ Designated as safety issue: Yes ]
  • Right ventricular function measured using transthoracic echocardiography (TTE) and TEE [ Time Frame: before and after the CPB ] [ Designated as safety issue: Yes ]
  • Serum levels of milrinone in relation with the pharmacodynamic marker [ Time Frame: pre CPB per CPB and post CPB ] [ Designated as safety issue: Yes ]
  • reduction of the composite index of hemodynamic complications (defined as hospital death, vasoactive drugs > 24 hours and post-op cardiac arrest), [ Time Frame: At Discharge ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Milrinone Inhaled in Cardiac Surgery
2- Inhaled Milrinone Prevents the Increase in Pulmonary Artery Pressure After CPB

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Valvular Stenosis
  • Valvular Insufficiency
  • Hypertension, Pulmonary
  • Coronary Artery Disease
  • Drug: Milrinone
    inhaled milrinone 5 mg (as for the injectable solution)
    Other Names:
    • Milrinone Cardiac Surgery
    • Milrinone inhaled
    • Inhaled milrinone reduces pulmonary artery pressure
  • Drug: Normal saline
    5 ml normal saline by inhalation over 15 min
    Other Names:
    • Placebo
    • Normal saline
    • Comparator
  • Placebo Comparator: Normal saline
    Normal saline by inhalation over 15 min
    Intervention: Drug: Normal saline
  • Active Comparator: Milrinone
    Inhaled milrinone 5 mg(as for the injectable solution)
    Intervention: Drug: Milrinone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
December 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00819377
08-1004
No
Andre Denault, Montreal Heart Institute
Andre Denault
  • Heart and stoke fondation of Quebec
  • Organon
  • Canadian Anesthesiologists' Society
Principal Investigator: Denault André, MD FRCPC Montreal Heart Institute
Montreal Heart Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP