Clinical trial NCT00838383: Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery
Official title: SELECTIVE ENDOTHELIN TYPE A RECEPTOR INHIBITION IN CARDIAC SURGERY SUBJECTS WITH PRE-EXISTING CARDIOVASCULAR RISK FACTORS: A DOSE CONFIRMATION STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-02-06
Enrollment: 29
Sex: ALL
Minimum age (years): 48
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Has been identified for coronary artery bypass grafting (CABG), aortic and/or mitral valve replacement, or combined CABG and cardiac valve replacement procedures that require cardiopulmonary bypass (CPB).

Exclusion Criteria:

* Requires an emergent or "emergency" CABG and/or cardiac valve replacement.

Primary outcomes:
measure: Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB)
timeFrame: 0 hour, 0.5 hour post-separation from CPB
measure: Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB)
timeFrame: 0 hour, 6 hour post-separation from CPB
measure: Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB)
timeFrame: 0 hour, 12 hour post-separation from CPB
measure: Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB)
timeFrame: 0 hour, 24 hour post-separation from CPB
measure: Mortality: Number of Participants Died During Surgery and Initial Hospitalization
timeFrame: During surgery, initial hospitalization period (up to 29 days for 1 mg/kg group, up to 44 days for 2 mg/kg dose group, up to 19 days for placebo group)
measure: Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation
timeFrame: Initial hospitalization period (up to 44 days)
Secondary outcomes:
measure: Number of Participants With Inotropic Requirements During the 24 Hours Postoperative Period
timeFrame: Immediately after cross-clamp removal up to 24 hours post-separation from CPB
measure: Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
timeFrame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
measure: Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
timeFrame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
measure: Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
timeFrame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
measure: Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
timeFrame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
measure: Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
timeFrame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
measure: Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
timeFrame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
measure: Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
timeFrame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
measure: Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
timeFrame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
measure: Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
timeFrame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
measure: Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
timeFrame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
measure: Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
timeFrame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
measure: Number of Participants With Unanticipated Perioperative and Postoperative Blood Requirements
timeFrame: 0 to 24 hours post-separation from CPB
measure: Duration of Assisted Ventilation
timeFrame: 0 hour up to 24 hours post-separation from CPB
measure: Duration of Intensive Care Unit (ICU) Stay
timeFrame: 0 hour post-separation from CPB up to 44 days
measure: Duration of Initial Postoperative Hospitalization
timeFrame: 0 hour post-separation from CPB up to 44 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania,
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: The Chattanooga Heart Institute
state: Tennessee
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: