Trial · NCT00838383
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 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. | percent change | MEAN |
| PRIMARY | 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 | 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. | percent change | MEAN |
| PRIMARY | 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 | 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. | percent change | MEAN |
| PRIMARY | 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 | 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. | percent change | MEAN |
| PRIMARY | 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) | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. | participants | NUMBER |
| PRIMARY | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | Initial hospitalization period (up to 44 days) | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. | participants | NUMBER |
| SECONDARY | 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 | Data was not collected, since this outcome was not analyzed as per Sponsor's discretion. | ||
| SECONDARY | 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 | 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. | liters per minute | MEAN |
| SECONDARY | 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 | 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. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | 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 | 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. | percentage of red blood cells in blood | MEAN |
| SECONDARY | 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 | 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. | beats per minute (bpm) | MEAN |
| 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) | 0, 0.5, 6, 12, 24 hours post-separation from CPB | 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. | mmHg | MEAN |
| 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) | 0, 0.5, 6, 12, 24 hours post-separation from CPB | 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. | mmHg | MEAN |
| SECONDARY | 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 | 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. | (dynes*second) per centimeter^5 | MEAN |
| 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) | 0, 0.5, 6, 12, 24 hours post-separation from CPB | 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. | percentage of oxygen saturation | MEAN |
| SECONDARY | 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 | 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. | (dynes*second) per centimeter^5 | MEAN |
| 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) | 0, 0.5, 6, 12, 24 hours post-separation from CPB | 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. | mmHg | MEAN |
| SECONDARY | 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 | 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. | milliliters (mL) | MEAN |
| SECONDARY | Number of Participants With Unanticipated Perioperative and Postoperative Blood Requirements | 0 to 24 hours post-separation from CPB | 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. | participants | NUMBER |
| SECONDARY | Duration of Assisted Ventilation | 0 hour up to 24 hours post-separation from CPB | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. | hours | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT00838383/outcomes