Patients referred for an isolated or a combined surgical correction of functional moderate to severe tricuspid regurgitation
Conditions
Brief summary
The primary end point is a composite element reflecting low cardiac output syndrome at 90 days: - 1) Catecholamine infusion persisting beyond 48 hours after cardiac surgery, - 2) Need for circulatory mechanical assist devices in the postoperative period, - 3) Need for renal replacement therapy at any time during intensive care unit stay.
Detailed description
1) Mortality at day 90, 2) Each component of the primary end point, 3) The study drug safety was assessed by recording of the incidence refractory hypotension was defined as a failure to increase mean arterial pressure above 60 mmHg despite optimal management.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point is a composite element reflecting low cardiac output syndrome at 90 days: - 1) Catecholamine infusion persisting beyond 48 hours after cardiac surgery, - 2) Need for circulatory mechanical assist devices in the postoperative period, - 3) Need for renal replacement therapy at any time during intensive care unit stay. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Mortality at day 90, 2) Each component of the primary end point, 3) The study drug safety was assessed by recording of the incidence refractory hypotension was defined as a failure to increase mean arterial pressure above 60 mmHg despite optimal management. | — |
Countries
France