Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery
- Conditions
- Cardiac Surgery SubjectsSubjects Undergoing CABG and/or Cardiac Valve Replacement
- Interventions
- Drug: Placebo
- Registration Number
- NCT00838383
- Lead Sponsor
- Pfizer
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- 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).
- Requires an emergent or "emergency" CABG and/or cardiac valve replacement.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - sitaxsentan (1.0 mg/kg) sitaxsentan (Thelin) - sitaxsentan (2.0 mg/kg) sitaxsentan (Thelin) -
- Primary Outcome Measures
Name Time Method Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB) 0 hour, 0.5 hour post-separation from 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.
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB) 0 hour, 6 hour post-separation from 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.
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB) 0 hour, 12 hour post-separation from 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.
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB) 0 hour, 24 hour post-separation from 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.
Mortality: Number of Participants Died During Surgery and Initial Hospitalization 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 who died during surgery or during initial hospitalization are reported here.
Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation Initial hospitalization period (up to 44 days) 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Inotropic Requirements During the 24 Hours Postoperative Period Immediately after cross-clamp removal up to 24 hours post-separation from CPB 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.
Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) 0, 0.5, 6, 12, 24 hours post-separation from CPB CO was calculated by multiplying stroke volume (SV) with heart rate (HR). It was used to evaluate the hemodynamic profile of each participant.
Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) 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) 0, 0.5, 6, 12, 24 hours post-separation from CPB The hematocrit is percentage of the volume of whole blood that is made up of red blood cells (RBCs).
Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) 0, 0.5, 6, 12, 24 hours post-separation from CPB Heart rate was assessed as one of the hemodynamic profile assessments at the specified time points.
Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) 0, 0.5, 6, 12, 24 hours post-separation from 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.
Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) 0, 0.5, 6, 12, 24 hours post-separation from 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.
Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) 0, 0.5, 6, 12, 24 hours post-separation from 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.
Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) 0, 0.5, 6, 12, 24 hours post-separation from 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.
Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) 0, 0.5, 6, 12, 24 hours post-separation from CPB SVR was calculated using formula: (\[mean systemic arterial pressure - mean right atrial pressure\] divided by CO)\*80, where CO= SV \* HR.
Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) 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) 0, 0.5, 6, 12, 24 hours post-separation from CPB Number of Participants With Unanticipated Perioperative and Postoperative Blood Requirements 0 to 24 hours post-separation from CPB 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.
Duration of Assisted Ventilation 0 hour up to 24 hours post-separation from CPB Assisted Ventilation time was the time (in hours) between intubation and extubation.
Duration of Intensive Care Unit (ICU) Stay 0 hour post-separation from CPB up to 44 days Duration of Initial Postoperative Hospitalization 0 hour post-separation from CPB up to 44 days The duration of initial postoperative hospitalization had been reported.
Trial Locations
- Locations (3)
University of Pennsylvania,
🇺🇸Philadelphia, Pennsylvania, United States
The Chattanooga Heart Institute
🇺🇸Chattanooga, Tennessee, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States