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

RecruitingPhase 2Ages 18 Years - anyAllMontreal Heart Institute
NCT05450328 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 admi

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📋 Eligibility rules (as published)
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.
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What it tests

  • Combined Epoprostenol Sodium & Milrinone
  • Normal saline
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Where

1 site
Montreal Heart Institute
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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