Inhaled Milrinone and Epoprostenol for the Prevention of Difficult Cardiac Pulmonary Bypass Separation
Status:
Not yet recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
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.