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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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Sepsis remains a global scourge. Before the SARS-CoV-2 pandemic, the World Health Organization estimated approximately 49 million cases annually, resulting in 11 million deaths. Defined by dysregulated host response to infection, sepsis leads to vital organ failure. Renal dysfunction affects about half of ICU patients, necessitating extracorporeal renal replacement therapy in approximately 10% of cases, alongside coagulation system involvement typified by thrombocytopenia. Immunothrombotic phenomena are pivotal in sepsis pathophysiology, activating coagulation and disrupting immune responses. Microcirculatory impairment, mediated by neutrophils, monocytes, and platelets, worsens vital organ perfusion. Excessive production of Neutrophil Extracellular Traps (NETs) is implicated in microcirculatory compromise during sepsis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemofiltration membranes (the oXiris® membrane and the HF1400 ® membrane) | Eligible patients for this study will undergo renal replacement therapy using two hemofiltration membranes commonly used in intensive care units. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemofiltration membranes (the oXiris membrane® and the HF1400® membrane) | Device | The PRISMAFLEX® or PRISMAX® control unit (pre- and post-dilution with a prescribed treatment dose > 25 ml/kg/h) with regional citrate anticoagulation and a substitution solution by PHOXILLUM will be used regardless of the type of membrane used (the oXiris membrane and the HF 1400 membrane), also as part of routine care provided in the ICU. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunothrombosis : Concentration of platelet activation markers | Dosages of platelet activation markers, before and after the renal replacement therapy membrane : oXiris membrane or conventional membrane | 12 months after inclusion day |
| Measure | Description | Time Frame |
|---|---|---|
| NETosis : Concentration of Neutrophil Extracellular Traps | Dosages of Neutrophil Extracellular Traps, before and after the renal replacement therapy membrane : oXiris membrane or conventional membrane | 12 months after inclusion day |
| Monocyte activation : Concentration of monocyte (CD14+) |
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Inclusion Criteria:
Patients aged 18 years and older
Admitted to the intensive care unit with septic shock, defined as an increase in the Sequential Organ Failure Assessment (SOFA) score of at least 2 points due to infection, requiring vasopressor drugs to maintain a mean arterial pressure (MAP) ≥ 65 mmHg, and a lactate level > 2 mmol/L (18 mg/dL) despite adequate fluid resuscitation
Requiring renal replacement therapy according to consensus indications:
Receiving continuous renal replacement therapy with a high-adsorption membrane (oXiris membrane) or a conventional membrane (HF1400 membrane)
Exclusion Criteria:
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Eligible patients for this study will undergo renal replacement therapy using two hemofiltration membranes commonly used in intensive care units
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine DEWITTE, Dr | Contact | 05 57 65 68 66 | +33 | antoine.dewitte@u-bordeaux.fr |
| Sarah CRONIER | Contact | 05 57 65 68 66 | +33 | sara.cronier@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Maria MAMANI, Pr | ImmunoConcEpT, Bordeaux University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Haut-Lévêque | Recruiting | Pessac | 33604 | France |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D000090882 | Thromboinflammation |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Blood samples will be collected in citrate and EDTA tubes before and after the membrane on the day of initiating renal replacement therapy (Day 0), the day after starting therapy (Day 1), and 5 days after (Day 5). Extraction of peripheral blood mononuclear cells (PBMCs) will be done.
|
Dosages of monocyte (CD14+), before and after the renal replacement therapy membrane : oXiris membrane or conventional membrane |
| 12 months after inclusion day |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |