Trial · NCT00838383
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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) | Number of participants who died during surgery or during initial hospitalization are reported here. |
| Primary | 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 | 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. |
| 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 | CO was calculated by multiplying stroke volume (SV) with heart rate (HR). It was used to evaluate the hemodynamic profile of each participant. |
| 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 | |
| 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 | The hematocrit is percentage of the volume of whole blood that is made up of red blood cells (RBCs). |
| 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 | Heart rate was assessed as one of the hemodynamic profile assessments at the specified time points. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | SVR was calculated using formula: (\[mean systemic arterial pressure - mean right atrial pressure\] divided by CO)\*80, where CO= SV \* HR. |
| 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 | |
| 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 | |
| Secondary | 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. |
| Secondary | 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. |
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.
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