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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.
Sitaxsentan (2.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.
Placebo will begin immediately following cross-clamp release and 12 hours post-CPB.
University of Pennsylvania,
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The Chattanooga Heart Institute
Chattanooga, Tennessee, United States
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB)
PVR in participants was derived from mean pulmonary artery pressure (PAP) (millimeter of mercury \[mmHg\]), pulmonary capillary wedge pressure (PCWP \[mmHg\]) and cardiac output (CO \[litres per minute\]). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= stroke volume (SV)\*heart rate (HR). Post-separation from CPB was the time immediately following cross-clamp release in CPB. Percent change in PVR at 0.5 hour post-separation from CPB in participants were summarized and reported.
Time frame: 0 hour, 0.5 hour post-separation from CPB
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB)
PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= SV \* HR. Percent change in PVR at 6 hour in participants were summarized and reported.
Time frame: 0 hour, 6 hour post-separation from CPB
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB)
PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= SV \* HR. Percent change in PVR at 12 hour in participants were summarized and reported.
Time frame: 0 hour, 12 hour post-separation from CPB
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB)
PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= SV \* HR. Percent change in PVR at 24 hour in participants were summarized and reported.
Time frame: 0 hour, 24 hour post-separation from CPB
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Mortality: Number of Participants Died During Surgery and Initial Hospitalization
Number of participants who died during surgery or during initial hospitalization are reported here.
Time frame: 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)
Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation
Number of participants with following incidents: myocardial infarction (Q and non-Q wave); stroke or cerebrovascular event (acute ischemia, hemorrhagic stroke or infarction, or a transient ischemia attack); hemodynamic collapse (requiring ventricular assistance devices) and re-operation (participants who returned to the operating room) during the initial hospitalization were reported.
Time frame: Initial hospitalization period (up to 44 days)
Number of Participants With Inotropic Requirements During the 24 Hours Postoperative Period
Participants were considered for inotropic requirements/therapy in case of either severe right ventricular failure or high pulmonary artery pressure, or if cardiac output was not maintained with epinephrine.
Time frame: Immediately after cross-clamp removal up to 24 hours post-separation from CPB
Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
CO was calculated by multiplying stroke volume (SV) with heart rate (HR). It was used to evaluate the hemodynamic profile of each participant.
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
The hematocrit is percentage of the volume of whole blood that is made up of red blood cells (RBCs).
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Heart rate was assessed as one of the hemodynamic profile assessments at the specified time points.
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. It was used to evaluate the hemodynamic profile of each participant.
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure. It was used to evaluate the hemodynamic profile of each participant.
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= SV \* HR.
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Venous oxygen saturation is the percentage of oxygen bound to hemoglobin in blood returning to the right side of the heart. It reflects the amount of oxygen "left over" after the tissues consumption.
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
SVR was calculated using formula: (\[mean systemic arterial pressure - mean right atrial pressure\] divided by CO)\*80, where CO= SV \* HR.
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Number of Participants With Unanticipated Perioperative and Postoperative Blood Requirements
Number of participants with unanticipated perioperative (occurring at or around the time of the surgery) and postoperative (period following the surgery) blood requirements were recorded on case report forms, summarized and reported in this outcome measure.
Time frame: 0 to 24 hours post-separation from CPB
Duration of Assisted Ventilation
Assisted Ventilation time was the time (in hours) between intubation and extubation.
Time frame: 0 hour up to 24 hours post-separation from CPB
Duration of Intensive Care Unit (ICU) Stay
Time frame: 0 hour post-separation from CPB up to 44 days
Duration of Initial Postoperative Hospitalization
The duration of initial postoperative hospitalization had been reported.
Time frame: 0 hour post-separation from CPB up to 44 days