Conditions: Cardiac Surgery Subjects Subjects Undergoing CABG and/or Cardiac Valve Replacement
Keywords: multi-center placebo-controlled randomized study of sitaxsentan administered to subjects post-cross-clamp release and 12 hours post-CPB
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 29
Healthy volunteers: no

Brief summary:
This is a multi-center, randomized study of sitaxsentan administered intravenously to subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and cardiac valve replacement procedures that require CPB.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: sitaxsentan (Thelin) intervention 2: sitaxsentan (Thelin) intervention 3: Placebo
Intervention descriptions: intervention 1: sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB. intervention 2: Sitaxsentan (2.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB. intervention 3: Placebo will begin immediately following cross-clamp release and 12 hours post-CPB.

Protocol document: