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

Launched by MONTREAL HEART INSTITUTE · Jul 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two inhaled medications, epoprostenol and milrinone, to help patients who have pulmonary hypertension during cardiac surgery. Pulmonary hypertension can make it difficult for the heart to function properly, especially when doctors are trying to separate patients from the heart-lung machine used during surgery. The trial will involve 142 participants, with half receiving the medications and the other half receiving a placebo (a substance with no active medication) before surgery. Researchers want to see if those who receive the inhaled treatments have a better chance of successfully transitioning off the heart-lung machine without needing extra medications or support.

To be eligible for this trial, participants must be at least 18 years old and scheduled for cardiac surgery that involves the use of a heart-lung machine. However, individuals with certain heart conditions, those needing urgent surgery, or those who might have adverse reactions to the medications will not be included. This trial is important because, if successful, it could improve the care and outcomes for patients with pulmonary hypertension undergoing heart surgery. Participants can expect to be closely monitored during and after their surgery to assess the effectiveness of the treatments.

Gender

ALL

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.