Cardiac Surgery Subjects, Subjects Undergoing CABG and/or Cardiac Valve Replacement
Conditions
Keywords
multi-center, placebo-controlled, randomized study of sitaxsentan administered to subjects post-cross-clamp release and 12 hours post-CPB
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.
Interventions
DRUGsitaxsentan (Thelin)
sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.
DRUGPlacebo
Placebo will begin immediately following cross-clamp release and 12 hours post-CPB.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
48 Years to 82 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. |
| 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. |
| 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 | — |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sitaxsentan (1 mg/kg) Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB). | 9 |
| Sitaxsentan (2 mg/kg) Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB. | 10 |
| Placebo Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB. | 10 |
| Total | 29 |
Baseline characteristics
| Characteristic | Sitaxsentan (1 mg/kg) | Sitaxsentan (2 mg/kg) | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 8.86 | 68.5 years STANDARD_DEVIATION 8.81 | 67.2 years STANDARD_DEVIATION 6.56 | 66.1 years STANDARD_DEVIATION 8.26 |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 9 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 9 | 9 / 10 | 9 / 10 |
| serious Total, serious adverse events | 2 / 9 | 5 / 10 | 4 / 10 |
Outcome results
Primary
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)
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Mortality: Number of Participants Died During Surgery and Initial Hospitalization | During surgery | 0 participants |
| Sitaxsentan (1 mg/kg) | Mortality: Number of Participants Died During Surgery and Initial Hospitalization | During initial hospitalization | 2 participants |
| Sitaxsentan (2 mg/kg) | Mortality: Number of Participants Died During Surgery and Initial Hospitalization | During surgery | 0 participants |
| Sitaxsentan (2 mg/kg) | Mortality: Number of Participants Died During Surgery and Initial Hospitalization | During initial hospitalization | 1 participants |
| Placebo | Mortality: Number of Participants Died During Surgery and Initial Hospitalization | During surgery | 0 participants |
| Placebo | Mortality: Number of Participants Died During Surgery and Initial Hospitalization | During initial hospitalization | 0 participants |
Primary
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)
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | Stroke or Cerebrovascular event | 0 participants |
| Sitaxsentan (1 mg/kg) | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | Hemodynamic collapse | 1 participants |
| Sitaxsentan (1 mg/kg) | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | Re-operation | 0 participants |
| Sitaxsentan (1 mg/kg) | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | Myocardial Infarction | 1 participants |
| Sitaxsentan (2 mg/kg) | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | Myocardial Infarction | 0 participants |
| Sitaxsentan (2 mg/kg) | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | Stroke or Cerebrovascular event | 0 participants |
| Sitaxsentan (2 mg/kg) | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | Hemodynamic collapse | 2 participants |
| Sitaxsentan (2 mg/kg) | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | Re-operation | 0 participants |
| Placebo | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | Hemodynamic collapse | 0 participants |
| Placebo | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | Myocardial Infarction | 0 participants |
| Placebo | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | Re-operation | 0 participants |
| Placebo | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | Stroke or Cerebrovascular event | 0 participants |
Primary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB) | -7.75 percent change | Standard Deviation 55.277 |
| Sitaxsentan (2 mg/kg) | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB) | -10.94 percent change | Standard Deviation 37.967 |
| Placebo | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 62.22 percent change | Standard Deviation 260.172 |
p-value: 0.530795% CI: [-291.3, 151.4]ANCOVA
p-value: 0.512195% CI: [-294.5, 148.2]ANCOVA
Primary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 31.42 percent change | Standard Deviation 67.887 |
| Sitaxsentan (2 mg/kg) | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB) | -12.32 percent change | Standard Deviation 37.517 |
| Placebo | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 98.03 percent change | Standard Deviation 283.333 |
p-value: 0.550595% CI: [-288, 154.8]ANCOVA
p-value: 0.323795% CI: [-331.7, 111]ANCOVA
Primary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 18.06 percent change | Standard Deviation 63.362 |
| Sitaxsentan (2 mg/kg) | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB) | -15.99 percent change | Standard Deviation 41.604 |
| Placebo | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 195.64 percent change | Standard Deviation 522.379 |
p-value: 0.141295% CI: [-389.6, 56.6]ANCOVA
p-value: 0.081395% CI: [-425, 25.5]ANCOVA
Primary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 39.36 percent change | Standard Deviation 61.615 |
| Sitaxsentan (2 mg/kg) | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB) | -12.01 percent change | Standard Deviation 39.561 |
| Placebo | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 173.68 percent change | Standard Deviation 511.269 |
p-value: 0.273595% CI: [-345.5, 99.3]ANCOVA
p-value: 0.122395% CI: [-396.8, 47.9]ANCOVA
Secondary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the last observation carried forward (LOCF) method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 1.32 liters per minute | Standard Deviation 1.552 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 0.38 liters per minute | Standard Deviation 2.138 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 5.48 liters per minute | Standard Deviation 2.036 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | 0.22 liters per minute | Standard Deviation 0.696 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 1.40 liters per minute | Standard Deviation 2.636 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 0.61 liters per minute | Standard Deviation 2.088 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 5.51 liters per minute | Standard Deviation 1.211 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -0.36 liters per minute | Standard Deviation 0.973 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 0.00 liters per minute | Standard Deviation 1.505 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 0.21 liters per minute | Standard Deviation 1.782 |
| Placebo | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 0.48 liters per minute | Standard Deviation 1.403 |
| Placebo | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 0.52 liters per minute | Standard Deviation 1.045 |
| Placebo | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 4.83 liters per minute | Standard Deviation 1.158 |
| Placebo | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 0.43 liters per minute | Standard Deviation 1.299 |
| Placebo | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | 0.16 liters per minute | Standard Deviation 0.532 |
Secondary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 0.00 millimeters of mercury (mmHg) | Standard Deviation 9.22 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 0.78 millimeters of mercury (mmHg) | Standard Deviation 10.146 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 9.89 millimeters of mercury (mmHg) | Standard Deviation 8.724 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | 2.11 millimeters of mercury (mmHg) | Standard Deviation 2.804 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 1.89 millimeters of mercury (mmHg) | Standard Deviation 9.649 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 5.70 millimeters of mercury (mmHg) | Standard Deviation 6.75 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 8.10 millimeters of mercury (mmHg) | Standard Deviation 5.425 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | 0.40 millimeters of mercury (mmHg) | Standard Deviation 1.578 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 3.80 millimeters of mercury (mmHg) | Standard Deviation 5.846 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 3.90 millimeters of mercury (mmHg) | Standard Deviation 6.74 |
| Placebo | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 0.78 millimeters of mercury (mmHg) | Standard Deviation 7.311 |
| Placebo | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 3.11 millimeters of mercury (mmHg) | Standard Deviation 7.044 |
| Placebo | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 9.22 millimeters of mercury (mmHg) | Standard Deviation 5.518 |
| Placebo | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 1.44 millimeters of mercury (mmHg) | Standard Deviation 6.54 |
| Placebo | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | 0.33 millimeters of mercury (mmHg) | Standard Deviation 4.301 |
Secondary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 8.11 beats per minute (bpm) | Standard Deviation 12.098 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 5.00 beats per minute (bpm) | Standard Deviation 21.593 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | 0 hour post-separation from CPB | 80.11 beats per minute (bpm) | Standard Deviation 13.851 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -1.56 beats per minute (bpm) | Standard Deviation 9.58 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 11.56 beats per minute (bpm) | Standard Deviation 17.35 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 1.10 beats per minute (bpm) | Standard Deviation 16.98 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | 0 hour post-separation from CPB | 84.50 beats per minute (bpm) | Standard Deviation 16.298 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -1.70 beats per minute (bpm) | Standard Deviation 11.225 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 0.00 beats per minute (bpm) | Standard Deviation 18.868 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 1.40 beats per minute (bpm) | Standard Deviation 13.074 |
| Placebo | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 0.80 beats per minute (bpm) | Standard Deviation 18.408 |
| Placebo | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 0.70 beats per minute (bpm) | Standard Deviation 21.474 |
| Placebo | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | 0 hour post-separation from CPB | 77.80 beats per minute (bpm) | Standard Deviation 9.102 |
| Placebo | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | -2.00 beats per minute (bpm) | Standard Deviation 11.804 |
| Placebo | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -2.80 beats per minute (bpm) | Standard Deviation 8.351 |
Secondary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 8.93 percentage of red blood cells in blood | Standard Deviation 4.013 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 9.64 percentage of red blood cells in blood | Standard Deviation 4.081 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | 0 hour post-separation from CPB | 25.56 percentage of red blood cells in blood | Standard Deviation 4.157 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | 1.77 percentage of red blood cells in blood | Standard Deviation 2.422 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 7.07 percentage of red blood cells in blood | Standard Deviation 4.06 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 6.82 percentage of red blood cells in blood | Standard Deviation 5.31 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | 0 hour post-separation from CPB | 26.46 percentage of red blood cells in blood | Standard Deviation 1.984 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | 3.29 percentage of red blood cells in blood | Standard Deviation 2.804 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 5.52 percentage of red blood cells in blood | Standard Deviation 3.862 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 5.77 percentage of red blood cells in blood | Standard Deviation 4.098 |
| Placebo | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 8.25 percentage of red blood cells in blood | Standard Deviation 3.925 |
| Placebo | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 7.68 percentage of red blood cells in blood | Standard Deviation 4.757 |
| Placebo | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | 0 hour post-separation from CPB | 25.30 percentage of red blood cells in blood | Standard Deviation 2.541 |
| Placebo | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 7.55 percentage of red blood cells in blood | Standard Deviation 5.204 |
| Placebo | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | 2.30 percentage of red blood cells in blood | Standard Deviation 2.541 |
Secondary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 2.88 mmHg | Standard Deviation 6.468 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 4.92 mmHg | Standard Deviation 7.253 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 3.12 mmHg | Standard Deviation 7.576 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | At 0 Hour post-separation from CPB | 19.27 mmHg | Standard Deviation 7.224 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -1.14 mmHg | Standard Deviation 4.765 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -3.51 mmHg | Standard Deviation 7.321 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 0.41 mmHg | Standard Deviation 8.832 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 0.22 mmHg | Standard Deviation 10.727 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | At 0 Hour post-separation from CPB | 26.02 mmHg | Standard Deviation 10.392 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 2.41 mmHg | Standard Deviation 7.834 |
| Placebo | Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 1.96 mmHg | Standard Deviation 9.046 |
| Placebo | Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | At 0 Hour post-separation from CPB | 20.81 mmHg | Standard Deviation 6.978 |
| Placebo | Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -0.41 mmHg | Standard Deviation 6.276 |
| Placebo | Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 2.41 mmHg | Standard Deviation 9.676 |
| Placebo | Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 3.80 mmHg | Standard Deviation 7.246 |
Secondary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 1.15 mmHg | Standard Deviation 15.24 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 6.30 mmHg | Standard Deviation 15.133 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 69.01 mmHg | Standard Deviation 13.887 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -5.80 mmHg | Standard Deviation 15.467 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 11.93 mmHg | Standard Deviation 13.039 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 1.97 mmHg | Standard Deviation 12.846 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 71.90 mmHg | Standard Deviation 12.768 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -3.70 mmHg | Standard Deviation 11.658 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 0.73 mmHg | Standard Deviation 11.124 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 8.20 mmHg | Standard Deviation 14.764 |
| Placebo | Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 8.00 mmHg | Standard Deviation 20.338 |
| Placebo | Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 0.39 mmHg | Standard Deviation 17.768 |
| Placebo | Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 72.55 mmHg | Standard Deviation 11.76 |
| Placebo | Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 3.04 mmHg | Standard Deviation 14.554 |
| Placebo | Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | 2.21 mmHg | Standard Deviation 13.509 |
Secondary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | 0.25 mmHg | Standard Deviation 3.694 |
| Sitaxsentan (1 mg/kg) | 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 Hour post-separation from CPB | 10.38 mmHg | Standard Deviation 7.652 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | -0.75 mmHg | Standard Deviation 7.005 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 0.38 mmHg | Standard Deviation 6.823 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | -0.25 mmHg | Standard Deviation 7.265 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 2.86 mmHg | Standard Deviation 5.146 |
| Sitaxsentan (2 mg/kg) | 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 Hour post-separation from CPB | 14.43 mmHg | Standard Deviation 4.962 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -0.43 mmHg | Standard Deviation 1.618 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 2.71 mmHg | Standard Deviation 4.152 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 3.57 mmHg | Standard Deviation 4.826 |
| Placebo | Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -0.88 mmHg | Standard Deviation 2.232 |
| Placebo | Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | -2.25 mmHg | Standard Deviation 6.519 |
| Placebo | Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 0.00 mmHg | Standard Deviation 6.949 |
| Placebo | 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 Hour post-separation from CPB | 12.50 mmHg | Standard Deviation 5.292 |
| Placebo | Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | -0.63 mmHg | Standard Deviation 4.868 |
Secondary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 7.40 (dynes*second) per centimeter^5 | Standard Deviation 58.674 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 19.31 (dynes*second) per centimeter^5 | Standard Deviation 66.92 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | At 0 Hour post-separation from CPB | 125.28 (dynes*second) per centimeter^5 | Standard Deviation 74.325 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -31.32 (dynes*second) per centimeter^5 | Standard Deviation 71.465 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 0.21 (dynes*second) per centimeter^5 | Standard Deviation 68.221 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | -33.53 (dynes*second) per centimeter^5 | Standard Deviation 95.697 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | At 0 Hour post-separation from CPB | 166.22 (dynes*second) per centimeter^5 | Standard Deviation 81.09 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -33.47 (dynes*second) per centimeter^5 | Standard Deviation 94.027 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | -29.66 (dynes*second) per centimeter^5 | Standard Deviation 98.021 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | -33.60 (dynes*second) per centimeter^5 | Standard Deviation 87.893 |
| Placebo | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 55.33 (dynes*second) per centimeter^5 | Standard Deviation 80.563 |
| Placebo | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 28.49 (dynes*second) per centimeter^5 | Standard Deviation 58.749 |
| Placebo | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | At 0 Hour post-separation from CPB | 112.79 (dynes*second) per centimeter^5 | Standard Deviation 59.363 |
| Placebo | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 33.99 (dynes*second) per centimeter^5 | Standard Deviation 89.573 |
| Placebo | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -4.04 (dynes*second) per centimeter^5 | Standard Deviation 52.134 |
Secondary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -117.39 (dynes*second) per centimeter^5 | Standard Deviation 229.848 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | -216.84 (dynes*second) per centimeter^5 | Standard Deviation 407.566 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 978.37 (dynes*second) per centimeter^5 | Standard Deviation 490.306 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 89.96 (dynes*second) per centimeter^5 | Standard Deviation 511.943 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | -80.49 (dynes*second) per centimeter^5 | Standard Deviation 358.157 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | -139.23 (dynes*second) per centimeter^5 | Standard Deviation 330.787 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | -63.12 (dynes*second) per centimeter^5 | Standard Deviation 343.174 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 26.74 (dynes*second) per centimeter^5 | Standard Deviation 384.919 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | 1.14 (dynes*second) per centimeter^5 | Standard Deviation 214.493 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 959.89 (dynes*second) per centimeter^5 | Standard Deviation 281.28 |
| Placebo | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | -8.37 (dynes*second) per centimeter^5 | Standard Deviation 663.864 |
| Placebo | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 1155.39 (dynes*second) per centimeter^5 | Standard Deviation 521.235 |
| Placebo | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -20.25 (dynes*second) per centimeter^5 | Standard Deviation 255.252 |
| Placebo | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | -77.92 (dynes*second) per centimeter^5 | Standard Deviation 673.047 |
| Placebo | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | -193.43 (dynes*second) per centimeter^5 | Standard Deviation 562.028 |
Secondary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 520.78 milliliters (mL) | Standard Deviation 637.651 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 664.78 milliliters (mL) | Standard Deviation 657.273 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 611.78 milliliters (mL) | Standard Deviation 785.27 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -42.11 milliliters (mL) | Standard Deviation 186.162 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 105.56 milliliters (mL) | Standard Deviation 196.365 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 124.50 milliliters (mL) | Standard Deviation 162.83 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | 0.50 milliliters (mL) | Standard Deviation 136.472 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 334.50 milliliters (mL) | Standard Deviation 325.358 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 358.00 milliliters (mL) | Standard Deviation 485.038 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 579.80 milliliters (mL) | Standard Deviation 641.39 |
| Placebo | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | 443.75 milliliters (mL) | Standard Deviation 790.672 |
| Placebo | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | 145.63 milliliters (mL) | Standard Deviation 244.298 |
| Placebo | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 107.50 milliliters (mL) | Standard Deviation 117.959 |
| Placebo | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | 367.50 milliliters (mL) | Standard Deviation 546.083 |
| Placebo | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | -16.88 milliliters (mL) | Standard Deviation 185.817 |
Secondary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | -3.00 percentage of oxygen saturation | Standard Deviation 11.328 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | -4.29 percentage of oxygen saturation | Standard Deviation 12.459 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 75.14 percentage of oxygen saturation | Standard Deviation 14.949 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | 0.14 percentage of oxygen saturation | Standard Deviation 6.644 |
| Sitaxsentan (1 mg/kg) | Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | -5.14 percentage of oxygen saturation | Standard Deviation 11.006 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | -8.50 percentage of oxygen saturation | Standard Deviation 7.191 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 73.25 percentage of oxygen saturation | Standard Deviation 10.053 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | 0.88 percentage of oxygen saturation | Standard Deviation 4.086 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | -8.75 percentage of oxygen saturation | Standard Deviation 4.803 |
| Sitaxsentan (2 mg/kg) | Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | -14.38 percentage of oxygen saturation | Standard Deviation 9.591 |
| Placebo | Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 24 hours post-separation from CPB | -0.78 percentage of oxygen saturation | Standard Deviation 6.815 |
| Placebo | Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 12 hours post-separation from CPB | -1.22 percentage of oxygen saturation | Standard Deviation 8.059 |
| Placebo | Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | At 0 hour post-separation from CPB | 72.44 percentage of oxygen saturation | Standard Deviation 22.305 |
| Placebo | Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 6 hours post-separation from CPB | -0.44 percentage of oxygen saturation | Standard Deviation 8.719 |
| Placebo | Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Change at 0.5 hours post-separation from CPB | 2.44 percentage of oxygen saturation | Standard Deviation 7.055 |
Secondary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Duration of Assisted Ventilation | 12 hours | Full Range 23.2 |
| Sitaxsentan (2 mg/kg) | Duration of Assisted Ventilation | 23 hours | Full Range 39.7 |
| Placebo | Duration of Assisted Ventilation | 21 hours | Full Range 10.6 |
Secondary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Duration of Initial Postoperative Hospitalization | 8 days | Full Range 8.2 |
| Sitaxsentan (2 mg/kg) | Duration of Initial Postoperative Hospitalization | 11 days | Full Range 13.5 |
| Placebo | Duration of Initial Postoperative Hospitalization | 10 days | Full Range 3.9 |
Secondary
Duration of Intensive Care Unit (ICU) Stay
Time frame: 0 hour post-separation from CPB up to 44 days
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Sitaxsentan (1 mg/kg) | Duration of Intensive Care Unit (ICU) Stay | 4 days | Full Range 2.5 |
| Sitaxsentan (2 mg/kg) | Duration of Intensive Care Unit (ICU) Stay | 6 days | Full Range 10.7 |
| Placebo | Duration of Intensive Care Unit (ICU) Stay | 5 days | Full Range 2.1 |
Secondary
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
Population: Data was not collected, since this outcome was not analyzed as per Sponsor's discretion.
Secondary
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
Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitaxsentan (1 mg/kg) | Number of Participants With Unanticipated Perioperative and Postoperative Blood Requirements | 0 participants |
| Sitaxsentan (2 mg/kg) | Number of Participants With Unanticipated Perioperative and Postoperative Blood Requirements | 3 participants |
| Placebo | Number of Participants With Unanticipated Perioperative and Postoperative Blood Requirements | 0 participants |