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Inhaled Milrinone and Epoprostenol for the Prevention of Difficult Cardiac Pulmonary Bypass Separation (MILAN)

Primary Purpose

Right Heart Failure, Right Ventricular Dysfunction

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Combined Epoprostenol Sodium & Milrinone
Normal saline
Sponsored by
Montreal Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Right Heart Failure focused on measuring Cardiac Surgery, Right Ventricular Dysfunction, Cardiopulmonary Bypass, Inhaled Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Only patients undergoing cardiac surgery with CPB and aged 18 years and older will be included in this study.

Exclusion Criteria:

  • The presence of congenital cardiomyopathy, which the correction is the primary objective of the proposed surgery. For example, a patient who requires surgery for atrial septal defect closure only would not be eligible for the study. On the other hand, a patient who undergoes this same surgery in addition to a valve replacement, for example, would be eligible to participate in the study.
  • Heart transplant or ventricular assist device surgery
  • Urgent surgery including hemodynamic instability requiring vasopressor agents upon arrival in the operating room
  • A contraindication to transesophageal ultrasound monitoring or the presence of an unstable cervical spine.
  • Presence of a contraindication related to Epoprostenol or Milrinone administration such as a documented left ventricular or right ventricular outflow tract obstruction, a severe unaddressed aortic stenosis, or a documented allergy to either of these two molecules.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Normal Saline

    Combination of inhaled Epoprostenol and Milrinone

    Arm Description

    The control group will receive a saline solution (8mL) as a placebo, before CPB start.

    The experimental group will receive simultaneously 4mg of Milrinone (1mg/mL, 4mL) and 60 mcg of Epoprostenol (15 mcg/mL, 4mL) before CPB initiation.

    Outcomes

    Primary Outcome Measures

    Proportion of patients who have a difficult CPB weaning in both groups
    To determine whether the use of inhaled Epoprostenol and Milrinone, prior to the initiation of CPB, decreases the occurrence of difficult CPB weaning compared to placebo administration.

    Secondary Outcome Measures

    Correlation between the variation of central venous pressure and patients who received the treatment
    To determine the effect of combined use of inhaled Epoprostenol and Milrinone, prior to the initiation of CPB on central venous pressure.
    Correlation between the variation of cardiac output and patients who received the treatment
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on cardiac output.
    Correlation between the variation of arterial pressure and patients who received the treatment
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on arterial pressure.
    Correlation between the right ventricular curve etiology (normal, square root, oblique) and patients who received the treatment
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on right ventricular curve etiology.
    Correlation between the PAM/ PAPM ratio taken at T0 and T1 and patients who received the treatment
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on PAM/PAPM ratio.
    Correlation between the cardiac index taken at T0 and T1 and patients who received the treatment
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on cardiac index.
    Correlation between right ventricular contractility and patients who received the treatment
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on the dp/dt calculated from the right ventricular waveform.
    Correlation between right ventricular outflow tract obstruction and patients who received the treatment
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on right ventricular systolic pressure and systolic pulmonary artery pressure variation.
    Correlation between cerebral saturation and patients who received the treatment
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on the cerebral saturation quantified by the near infrared spectroscopy.
    Correlation between fluid administration during surgery and patients who received the treatment
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on fluid administration during surgery such as crystalloid, colloid and blood transfusion.
    Correlation between the vasoactive and inotropic score and patients who received the treatment
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on the vasoactive and inotropic score quantified on the patient arrival in the ICU.
    Correlation between the time of persistent organ dysfunction (TPOD) and patients who received the treatment
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on the TPOD.
    Correlation between the ICU stay and patients who received the treatment
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on the ICU stay.
    Correlation between the post-operative complications and patients who received the treatment
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on post-operative complications defined by the Society of Thoracic Surgeons and patients who received the treatment.

    Full Information

    First Posted
    May 16, 2022
    Last Updated
    July 5, 2022
    Sponsor
    Montreal Heart Institute
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05450328
    Brief Title
    Inhaled Milrinone and Epoprostenol for the Prevention of Difficult Cardiac Pulmonary Bypass Separation
    Acronym
    MILAN
    Official Title
    Inhaled Milrinone and Epoprostenol for the Prevention of Difficult Cardiac Pulmonary Bypass Separation: A Randomized, Double-blind, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    April 1, 2023 (Anticipated)
    Study Completion Date
    April 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Montreal Heart Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In cardiac surgery, the presence of pulmonary hypertension (PH) is a prognostic factor associated with increased mortality and morbidity. In this context, one of the main causes of PH is related to reperfusion ischemia during weaning from extracorporeal circulation (CPB). One of the consequences of PH is right ventricular dysfunction. During weaning from CPB, the development of a right ventricular dysfunction is associated with increased requirements for vasopressor and inotropic agents, duration of mechanical ventilation, prolonged intensive care and hospital stay, and increased mortality compared with patients with left ventricular (LV) dysfunction. The management of patients with PH with or without right ventricular (RV) dysfunction relies on several strategies such as the administration of intravenous and inhaled agents, or mechanical ventricular support. Among those agents, the administration of inotropes or pulmonary vasodilators such as epoprostenol, milrinone and nitric oxide are among the most widely used treatments recommended by the Canadian Cardiovascular Society. At the Montreal Heart Institute, inhaled epoprostenol and milrinone are routinely administered to patients with PH or LV dysfunction in the perioperative setting. Despite the frequent use of inhaled epoprostenol and milrinone, Health Canada has not yet approved the use of these molecules. The primary objective of this multicenter, double-blind, randomized clinical trial is to evaluate the clinical efficacy of the combined administration of inhaled epoprostenol and milrinone in a cardiac surgery setting. This trial will compare the clinical outcome of 71 patients who will receive inhaled epoprostenol and milrinone before the start of bypass surgery to 71 patients who will receive a placebo before the start of the CPB. The primary clinical outcome is the proportion of patients with an "unsuccessful" CPB weaning defined by the use of an inotrope +/- vasopressor agent or the use of mechanical circulatory support or a return to bypass grafting for hemodynamic reasons. This clinical trial will evaluate the clinical efficacy of the combination of inhaled agents in a cardiac surgery setting. Therefore, if the results of this study are positive, the combination of inhaled epoprostenol and milrinone will optimize the management of patients with pulmonary hypertension with or without a right ventricular dysfunction.
    Detailed Description
    Hypothesis: Based on the knowledge gained from previous work, the administration of inhaled Milrinone and Epoprostenol therapy prior to the initiation of cardiopulmonary bypass (CPB) is superior in terms of favourable clinical outcomes. The combined administration of these agents improves right ventricular performance while reducing myocardial and pulmonary ischemia-reperfusion injury secondary to weaning from bypass surgery. For these reasons, we hypothesize that administration of combination therapy before the start of CPB may provide better hemodynamic stability throughout the surgery and favourable postoperative clinical outcomes. Objective: Primary Objective To determine whether the use of inhaled Epoprostenol and Milrinone, prior to the initiation of CPB, decreases the occurrence of difficult CPB weaning compared to placebo administration. Secondary Objectives To determine the effect of combined use of inhaled Epoprostenol and Milrinone, prior to the initiation of CPB on hemodynamic and perioperative parameters. To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on postoperative clinical outcomes. Design: The proposed study is a randomized, double-blind, controlled trial to determine the efficacy of the combined use of inhaled Epoprostenol and Milrinone prior to the initiation of CPB compared with the use of a placebo in a cardiac surgery setting. The clinical outcome of interest is the incidence of a difficult weaning from CPB. A difficult weaning is defined as the use of an inotrope with or without a vasopressor agent or the use of mechanical circulatory support or a return on CPB for hemodynamic reasons. Patients/Participants: Inclusion Criteria Only patients undergoing cardiac surgery with CPB and aged 18 years and older will be included in this study. Interventions: We will randomly assign the 142 patients in a 1:1 allocation scheme to receive a combination of inhaled Epoprostenol and Milrinone or a placebo after induction of general anesthesia, i.e. before CPB initiation. Free and informed consent to participate in this research project will be obtained the day before surgery by the anesthesiologist in charge of the case or by a member of the research team. In both study groups, the anesthetic procedure will be performed according to Canadian practice standards and is left to the discretion of the clinician. In both groups, the procedure will be administered via an ultrasonic nebulizer (Aeroneb Professional Nebulizer System, Aerogen Ltd, Galway, Ireland, registration number: 66728) over a period of 20 minutes. This type of nebulizer is used routinely at the Montreal Heart Institute and can hold a maximum of 8 mL of solutions. The experimental group will receive simultaneously 4mg of Milrinone (1mg/mL, 4mL) and 60 mcg of Epoprostenol (15 mcg/mL, 4mL) before CPB initiation. The control group will receive a saline solution (8mL) as a placebo, before CPB start. For each patient, 2 syringes of 4mL will be prepared on the morning of surgery, depending on the allocation group, to ensure drug stability. For example, for patients in the experimental group, one syringe containing 4mg of milrinone (1mg/mL, 4mL) and one syringe containing 60 mcg of epoprostenol (15 mcg/mL, 4mL) will be prepared. For the control group, two syringes containing 4mL of 0.9% physiological saline will be prepared. Expected outcomes: The administration of this combination therapy prior to the start CPB may decrease the proportion of patients presenting a difficult CPB weaning, in addition to better hemodynamic stability during surgery. Also, we believe that patients who have received the combined therapy will have favourable postoperative clinical outcomes, such as less vasoactive and inotropic agents and a reduction in the duration of postoperative organ dysfunction. This randomized, double-blind, multicenter, controlled clinical trial will evaluate the clinical efficacy of the combination of inhaled agents in cardiac surgery setting intraoperatively and postoperatively. Therefore, if the results of this study are positive, the combination of inhaled Epoprostenol and Milrinone will optimize the management of patients with pulmonary hypertension with or without right ventricular dysfunction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Right Heart Failure, Right Ventricular Dysfunction
    Keywords
    Cardiac Surgery, Right Ventricular Dysfunction, Cardiopulmonary Bypass, Inhaled Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    141 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Normal Saline
    Arm Type
    Placebo Comparator
    Arm Description
    The control group will receive a saline solution (8mL) as a placebo, before CPB start.
    Arm Title
    Combination of inhaled Epoprostenol and Milrinone
    Arm Type
    Active Comparator
    Arm Description
    The experimental group will receive simultaneously 4mg of Milrinone (1mg/mL, 4mL) and 60 mcg of Epoprostenol (15 mcg/mL, 4mL) before CPB initiation.
    Intervention Type
    Drug
    Intervention Name(s)
    Combined Epoprostenol Sodium & Milrinone
    Intervention Description
    One syringe containing 4mg of milrinone (1mg/mL, 4mL) and one syringe containing 60 mcg of epoprostenol (15 mcg/mL, 4mL). The drugs will be administered via an ultrasonic nebulizer (Aeroneb Professional Nebulizer System, Aerogen Ltd, Galway, Ireland, registration number: 66728) over a period of 20 minutes. This type of nebulizer is used routinely at the Montreal Heart Institute and can hold a maximum of 8 mL of solutions.
    Intervention Type
    Drug
    Intervention Name(s)
    Normal saline
    Intervention Description
    The control group will receive two syringes of 4mL of Normal Saline, before CPB start. The placebo will be administered via an ultrasonic nebulizer (Aeroneb Professional Nebulizer System, Aerogen Ltd, Galway, Ireland, registration number: 66728) over a period of 20 minutes. This type of nebulizer is used routinely at the Montreal Heart Institute and can hold a maximum of 8 mL of solutions.
    Primary Outcome Measure Information:
    Title
    Proportion of patients who have a difficult CPB weaning in both groups
    Description
    To determine whether the use of inhaled Epoprostenol and Milrinone, prior to the initiation of CPB, decreases the occurrence of difficult CPB weaning compared to placebo administration.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Correlation between the variation of central venous pressure and patients who received the treatment
    Description
    To determine the effect of combined use of inhaled Epoprostenol and Milrinone, prior to the initiation of CPB on central venous pressure.
    Time Frame
    1 year
    Title
    Correlation between the variation of cardiac output and patients who received the treatment
    Description
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on cardiac output.
    Time Frame
    1 year
    Title
    Correlation between the variation of arterial pressure and patients who received the treatment
    Description
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on arterial pressure.
    Time Frame
    1 year
    Title
    Correlation between the right ventricular curve etiology (normal, square root, oblique) and patients who received the treatment
    Description
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on right ventricular curve etiology.
    Time Frame
    1 year
    Title
    Correlation between the PAM/ PAPM ratio taken at T0 and T1 and patients who received the treatment
    Description
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on PAM/PAPM ratio.
    Time Frame
    1 year
    Title
    Correlation between the cardiac index taken at T0 and T1 and patients who received the treatment
    Description
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on cardiac index.
    Time Frame
    1 year
    Title
    Correlation between right ventricular contractility and patients who received the treatment
    Description
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on the dp/dt calculated from the right ventricular waveform.
    Time Frame
    1 year
    Title
    Correlation between right ventricular outflow tract obstruction and patients who received the treatment
    Description
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on right ventricular systolic pressure and systolic pulmonary artery pressure variation.
    Time Frame
    1 year
    Title
    Correlation between cerebral saturation and patients who received the treatment
    Description
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on the cerebral saturation quantified by the near infrared spectroscopy.
    Time Frame
    1 year
    Title
    Correlation between fluid administration during surgery and patients who received the treatment
    Description
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on fluid administration during surgery such as crystalloid, colloid and blood transfusion.
    Time Frame
    1 year
    Title
    Correlation between the vasoactive and inotropic score and patients who received the treatment
    Description
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on the vasoactive and inotropic score quantified on the patient arrival in the ICU.
    Time Frame
    1 year
    Title
    Correlation between the time of persistent organ dysfunction (TPOD) and patients who received the treatment
    Description
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on the TPOD.
    Time Frame
    1 year
    Title
    Correlation between the ICU stay and patients who received the treatment
    Description
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on the ICU stay.
    Time Frame
    1 year
    Title
    Correlation between the post-operative complications and patients who received the treatment
    Description
    To determine the effect of combined use of inhaled Epoprostenol and milrinone, prior to the initiation of CPB on post-operative complications defined by the Society of Thoracic Surgeons and patients who received the treatment.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - Only patients undergoing cardiac surgery with CPB and aged 18 years and older will be included in this study. Exclusion Criteria: The presence of congenital cardiomyopathy, which the correction is the primary objective of the proposed surgery. For example, a patient who requires surgery for atrial septal defect closure only would not be eligible for the study. On the other hand, a patient who undergoes this same surgery in addition to a valve replacement, for example, would be eligible to participate in the study. Heart transplant or ventricular assist device surgery Urgent surgery including hemodynamic instability requiring vasopressor agents upon arrival in the operating room A contraindication to transesophageal ultrasound monitoring or the presence of an unstable cervical spine. Presence of a contraindication related to Epoprostenol or Milrinone administration such as a documented left ventricular or right ventricular outflow tract obstruction, a severe unaddressed aortic stenosis, or a documented allergy to either of these two molecules.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stephanie Jarry, PhD (c)
    Phone
    5149289258
    Email
    stephanie.jarry.1@umontreal.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    André Denault, MD, PhD
    Phone
    5143763330
    Ext
    3732
    Email
    andre.denault@umontreal.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Inhaled Milrinone and Epoprostenol for the Prevention of Difficult Cardiac Pulmonary Bypass Separation

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