Trial · NCT03229538
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome | Until hospital discharge, up to 4 months | A composite mortality, major morbidity and length of stay global rank endpoint with endpoints ranked according to severity. For this endpoint, each randomized patient will be assigned a rank based upon their most-severe outcome. Rank of 91 = Post-operative length of stay \> 90 days, 92 = Post-op cardiac arrest, multi-system organ failure, renal failure with temporary dialysis, or prolonged ventilator support, 93 = Reoperation for bleeding, unplanned delayed sternal closure, or post-op unplanned interventional cardiac catheterization, 94 = Post-operative mechanical circulatory support or unplanned cardiac reoperation (exclusive of reoperation for bleeding), 95 = Renal failure with permanent dialysis, neurologic deficit persistent at discharge, or respiratory failure requiring tracheostomy; 96 = Heart transplant (during hospitalization); 97 = Operative mortality. Ranks 1 through 90 correspond to the post-operative length of stay in days. |
| Secondary | Number of Participants With Mortality, Including In-hospital Mortality or Mortality After Hospital Discharge But Within 30 Days of the Last Dose of Study Drug | up to 30 days | |
| Secondary | Number of Participants With Death or Major Complication as Defined by an Outcome in One of the 7 Highest Global Ranking Categories | Until hospital discharge, up to 4 months | The 7 highest global ranking categories range from 91 (postoperative length of hospital stay \> 90 days) to 97 (operative mortality). |
| Secondary | Number of Participants With a Post-operative Length of Stay Greater Than 90 Days | Until hospital discharge, up to 4 months | Calculated as discharge date minus surgery date. |
| Secondary | Number of Participants With Prolonged Mechanical Ventilation (Greater Than 7 Days) | Until hospital discharge, up to 4 months | |
| Secondary | Number of Participants With Post-operative Low Cardiac Output Syndrome | Until hospital discharge, up to 4 months | Based upon the STS-CHSD registry defined "cardiac dysfunction resulting in low cardiac output" complication variable. |
| Secondary | Number of Participants With Occurrence of Any One or More of the Following STS-CHSD-defined Major Post-operative Infectious Complications: Postprocedural Infective Endocarditis, Pneumonia, Sepsis, Deep Wound Infection, Mediastinitis. | Until hospital discharge, up to 4 months | |
| Secondary | Number of Participants With Any Other Post-operative Complications From the Start of Study Drug Administration Until Hospital Discharge. | Until hospital discharge, up to 4 months | |
| Secondary | PK/PD - Time to Maximum Concentration (Tmax) | Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB) | |
| Secondary | PK/PD - Maximum Concentration (Cmax) | Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB) | |
| Secondary | PK/PD - Clearance (CL) | Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB) | |
| Secondary | PK/PD - Volume of Distribution (Vd) | Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB) | |
| Secondary | Post-operative Biomarkers of the Inflammatory Response to Cardiopulmonary Bypass Including Interleukins 6 and 8 | Pre-2nd dose; a minimum of 2 of any of the following 5 time points (0-30 min after the start of CPB, 0-30 min after MUF, 1-2 hrs after CPB end, 4-6 hrs after CPB end, or 16-24 hrs after CPB end); and 36-48 hrs after CPB end | Only to be collected at select centers and in those patients whose parent/legally authorized representative have granted consent to blood draws |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03229538/registered