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| Name | Class |
|---|---|
| Vantive Health LLC | INDUSTRY |
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The goal of this clinical trial is to evaluate if a blood purification treatment called "Oxiris" works to help adults with septic shock. The main questions it aims to answer are: (1) Does Oxiris treatment lower the risk of death or organ failure within the first 7 days? (2) Does Oxiris treatment lower the level of inflammation in the body? Researchers will compare participants who receive Oxiris treatment to a group of participants who receive standard medical care to see if Oxiris helps them recover better.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxiris Treatment Group | Experimental | Participants in this arm will receive extracorporeal blood purification therapy using the Oxiris filter (Baxter) for the management of septic shock. The intervention consists of continuous venovenous hemodiafiltration (CVVHDF) for up to 72 hours, with the Oxiris filter replaced every 24 hours to maximize adsorption efficacy. For patients not requiring renal replacement therapy (RRT), slow continuous ultrafiltration (SCUF) will be performed for adsorption therapy only. All participants will also receive standard intensive care according to institutional protocols. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxiris Filter (Blood Purification Device) | Device | The Oxiris filter (Baxter) will be used for extracorporeal blood purification in patients with septic shock.
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| Measure | Description | Time Frame |
|---|---|---|
| Composite of early organ dysfunction and mortality at Day 7 | This is a composite outcome defined as either an increase in Sequential Organ Failure Assessment (SOFA) score of 2 points or more from baseline, or death from any cause, within 7 days after the start of Oxiris treatment. The SOFA score measures the function of six organ systems (respiratory, cardiovascular, hepatic, coagulation, renal, and neurological), with higher scores indicating more severe organ dysfunction. | 7 days after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Percentage of participants who died from any cause | Day 28 |
| Change in Sequential Organ Failure Assessment(SOFA) score | Change in the Sequential Organ Failure Assessment (SOFA) score from baseline to Day 3 (Higher scores mean a worse outcome) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Woohyun Cho, M.D., Ph.D | Contact | 82-55-360-4821 | popoyes@hanmail.net |
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IPD will not be shared to protect the privacy of study participants. The data contains sensitive clinical information, and the current IRB approval and informed consent do not include provisions for public data sharing with external researchers.
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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This is a multicenter, single-arm interventional study designed to evaluate the efficacy of Oxiris-based blood purification therapy in patients with septic shock. To evaluate the treatment effect, the study will use an external control group from the Korean Sepsis Alliance (KSA) registry, a large-scale prospective observational cohort. Researchers will apply 1:2 propensity score matching based on age, sex, comorbidities, initial SOFA score, and site of infection to compare the Oxiris-treated group with the control group.
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| Day 3 |
| Change in Procalcitonin | Change in serum procalcitonin levels as an inflammatory marker | Day 3 |
| Change in IL-6 | Change in Interleukin-6 levels (if measured). | Day 3 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |