SELECTIVE ENDOTHELIN TYPE A RECEPTOR INHIBITION IN CARDIAC SURGERY SUBJECTS WITH PRE-EXISTING CARDIOVASCULAR RISK FACTORS: A DOSE CONFIRMATION STUDY
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 48 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Requires an emergent or "emergency" CABG and/or cardiac valve replacement.
研究组 & 干预措施
sitaxsentan (1.0 mg/kg)
干预措施: sitaxsentan (Thelin) (Drug)
sitaxsentan (2.0 mg/kg)
干预措施: sitaxsentan (Thelin) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Duration of Assisted Ventilation(0 hour up to 24 hours post-separation from CPB)
- 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)