Trial · NCT07902024
Registered outcomes47
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 47
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in SOFA score from baseline to Day 7 | From baseline (before the first dose) to Day 7 | The Sequential Organ Failure Assessment (SOFA) score is a measure of organ dysfunction (range 0-24, with higher scores indicating more severe dysfunction). The primary endpoint is the improvement between the four groups, defined as baseline SOFA score minus Day 7 SOFA score. SOFA score is assessed at baseline (before the first dose) and on Day 7. |
| Secondary | All-cause mortality at 28 days | 28 days | All-cause mortality at 28 days after enrollment. |
| Secondary | Duration of intensive care unit (ICU) stay | From enrollment to ICU discharge (assessed up to Day 28) | Duration of ICU stay, calculated from ICU admission to ICU discharge using medical records and reported in days. |
| Secondary | Duration of total hospital stay | From enrollment to hospital discharge (assessed up to Day 28) | Total hospital length of stay, calculated from hospital admission to hospital discharge using medical records and reported in days. |
| Secondary | Change in prothrombin time (PT) from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | PT will be measured in plasma using an automated coagulation analyzer and reported in seconds. |
| Secondary | Change in activated partial thromboplastin time (APTT) from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | APTT will be measured in plasma using an automated coagulation analyzer and reported in seconds. |
| Secondary | Change in international normalized ratio (INR) from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | INR will be calculated from prothrombin time using an automated coagulation analyzer and reported as a dimensionless ratio. |
| Secondary | Change in fibrinogen concentration from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | Fibrinogen concentration will be measured in plasma using an automated coagulation analyzer and reported in g/L. |
| Secondary | Change in D-dimer concentration from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | D-dimer concentration will be measured in plasma using an immunoassay and reported in mg/L fibrinogen-equivalent units (FEU). |
| Secondary | Change in platelet count from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | Platelet count will be measured in whole blood using an automated hematology analyzer and reported as ×10⁹/L. |
| Secondary | Change in white blood cell (WBC) count from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | WBC count will be measured in whole blood using an automated hematology analyzer and reported as ×10⁹/L. |
| Secondary | Change in neutrophil percentage from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | Neutrophil percentage will be measured in whole blood using an automated hematology analyzer and reported as a percentage of total leukocytes. |
| Secondary | Change in C-reactive protein (CRP) concentration from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | CRP concentration will be measured in serum using an immunoassay and reported in mg/L. |
| Secondary | Change in procalcitonin (PCT) concentration from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | PCT concentration will be measured in serum using an immunoassay and reported in ng/mL. |
| Secondary | Change in lactate concentration from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | Lactate concentration will be measured in arterial blood using a blood gas analyzer and reported in mmol/L. |
| Secondary | Change in arterial blood pH from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | Arterial blood pH will be measured using a blood gas analyzer and reported as a dimensionless value. |
| Secondary | Change in arterial partial pressure of oxygen (PaO2) from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | PaO2 will be measured in arterial blood using a blood gas analyzer and reported in mmHg. |
| Secondary | Change in arterial partial pressure of carbon dioxide (PaCO2) from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | PaCO2 will be measured in arterial blood using a blood gas analyzer and reported in mmHg. |
| Secondary | Change in alanine aminotransferase (ALT) concentration from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | ALT will be measured in serum using an automated biochemical analyzer and reported in U/L. |
| Secondary | Change in aspartate aminotransferase (AST) concentration from baseline to Day 28 | Days 1, 3, 5, 7, 14, 21, and 28 | AST will be measured in serum using an automated biochemical analyzer and reported in U/L. |
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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