Levosimendan Versus Placebo Before Tricuspid Valve Surgery in Patients With Right Ventricular Dysfunction
Status:
Not yet recruiting
Trial end date:
2024-09-30
Target enrollment:
Participant gender:
Summary
A Prospective, multicenter, randomized (two arms, parallel groups); double-blind,
placebo-controlled in order to assess the ability of preoperative levosimendan to prevent
post-operative low cardiac output in high-risk patients referred to cardiac surgery for
correcting functional tricuspid regurgitation. The primary end point is a composite element
that includes peri-operative mortality and low cardiac output syndrome at day-90: 1)
catecholamine infusion persisting beyond 48 hours after cardiac surgery, 2) the need for
circulatory mechanical assist devices in the postoperative period, 3) or the need for renal
replacement therapy at any time during intensive care unit stay. If a patient had at least 1
of these criteria, he or she was considered as meeting the primary end point.The secondary
end points were 1) each component of the primary end point, and 2) the study drug safety
defined as refractory hypotension.