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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A03366-47 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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Sepsis is a major cause of death in Intensive Care Units and therefore finding new therapies to improve survival rates and limit morbidity is a major goal. Over the past decades, blood purification has been proposed as an adjuvant therapy for sepsis. The goal of blood purification is to restore the immune homeostasis and efficiency through the removal of bacterial products including endotoxins, broad-spectrum cytokines and other inflammatory mediators. Indeed, the large and overwhelmed release of these mediators in the early phase of sepsis may induce multiple organ failure syndrome. In 2017, different techniques are proposed for blood purification. Among them, the highly adsorptive membrane, oXiris™, seems promising. This membrane can be used in case of Acute Kidney Injury associated with sepsis and exhibits enhanced blood purification capacities. Previous studies on animals have already proven that this membrane can remove broad-spectrum cytokines but also endotoxins from the blood. This ability to remove endotoxins is particularly interesting since endotoxins are believed to be the trigger of the immune cascade at the initiation of sepsis.
The lack of clinical evidence is the main limit to a wider use of this membrane. Therefore, the aim of the present clinical trial is to characterize the blood purification properties of the membrane in a human clinical setting. The oXiris™ membrane is specifically designed to improve the adsorptive capacities of the polyacrylonitrile-based AN69 membrane. Its extremely rich coating of polyethyleneimine (PEI) gives the membrane the ability to bind and remove not only cytokines but also endotoxins due to the positive charges of PEI at the surface of the membrane. The tested hypothesis is that the oXiris™ filter allows for a greater endotoxin and cytokine removal compared to a standard polysulfone ("PrismafleX HF1400") filter in patients with septic shock.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVVH using oXiris™ filter | Experimental | Patients included in this arm will have renal replacement therapy by performing Continuous Veno-Venous Hemofiltration (CVVH) using oXiris™ membrane. They will also have arterial blood sampling and ultrafiltrate sampling during the CVVH. |
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| CVVH using PrismafleX HF1400 filter | Active Comparator | Patients included in this arm will have renal replacement therapy by performing CVVH using a standard polysulfone filter (PrismafleX HF1400). They will also have arterial blood sampling and ultrafiltrate sampling during the CVVH. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arterial blood sampling | Biological | All patients will have arterial blood sampling to assess pre-filter and post-filter plasma endotoxin mass and activity and plasma cytokine levels |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin 6 (IL-6) plasmatic concentration | 24 hours after the initiation of CVVH | |
| Endotoxin plasmatic mass concentration | 24 hours after the initiation of CVVH |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-filter plasma endotoxin mass | At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH | |
| Pre-filter plasma endotoxin activity | At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas RIMMELE, MD, PhD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Universitaire de Clermont Ferrand | Clermont-Ferrand | 63003 | France | |||
| CHU Francois Mitterrand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34519356 | Derived | Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2. |
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| Ultrafiltrate sampling | Biological | All patients will have ultrafiltrate sampling to assess cytokine levels |
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| CVVH using oXiris™ filter | Device | Patients included in the experimental arm will have renal replacement therapy by performing CVVH using oXiris™ filter |
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| CVVH using PrismafleX HF1400 filter | Device | Patients included in the experimental arm will have renal replacement therapy by performing CVVH using PrismafleX HF1400 filter |
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| Post-filter plasma endotoxin mass | 1, 4, 12 and 24 hours after the initiation of CVVH |
| Post-filter plasma endotoxin activity | 1, 4, 12 and 24 hours after the initiation of CVVH |
| Pre-filter plasma cytokine level | At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH |
| Post-filter plasma cytokine level | 1, 4, 12 and 24 hours after the initiation of CVVH |
| Ultrafiltrate cytokine level | 1, 4, 12 and 24 hours after the initiation of CVVH |
| Pre-filter plasma lipids level | At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH |
| Post-filter plasma lipids level | 1, 4, 12 and 24 hours after the initiation of CVVH |
| Pre-filter plasma Procalcitonin level | At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH |
| Post-filter plasma Procalcitonin level | 1, 4, 12 and 24 hours after the initiation of CVVH |
| Pre-filter plasma Phospholipid Transfer Protein level | At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH |
| Post-filter plasma Phospholipid Transfer Protein level | 1, 4, 12 and 24 hours after the initiation of CVVH |
| Pre-filter plasma Cholesteryl Ester Transfer Protein level | At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH |
| Post-filter plasma Cholesteryl Ester Transfer Protein level | 1, 4, 12 and 24 hours after the initiation of CVVH |
| Pre-filter plasma lipopolysaccharide (LPS) Binding Protein level | At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH |
| Post-filter plasma LPS-Binding Protein level | 1, 4, 12 and 24 hours after the initiation of CVVH |
| Norepinephrine requirements | 4, 12 and 24 hours after the initiation of CVVH |
| Fluids infused | 4, 12 and 24 hours after the initiation of CVVH |
| Patient survival | At day 7 |
| Patient survival | At day 30 |
| Patient survival | At day 90 |
| Comparison of the results obtained on the above-mentioned parameters, according to the type of bacteria identified from standard care microbiological exams. | At day 7 |
| Dijon |
| 21033 |
| France |
| CHU Dijon - Bocage central | Dijon | 21079 | France |
| L'Hôpital Nord-Ouest - Villefranche sur Saone | Gleizé | 69400 | France |
| Anesthesia and Critical Care Medicine Department - Edouard Herriot Hospital | Lyon | 69003 | France |
| Clinique de la Sauvegarde | Lyon | 69337 | France |
| Hôpital Pasteur 2 - Hôpital Universitaire de Nice | Nice | 06000 | France |
| Hopital Haut Lévèque - CHU Bordeaux | Pessac | 33600 | France |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D010538 | Peritonitis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D059413 | Intraabdominal Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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