Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Endotoxins and Cytokines Removal During Continuous Hemofiltration With oXiris™
Brief Summary: 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.


Options:
A: Arm Label: CVVH using oXiris™ filter; Type: EXPERIMENTAL; Interventions: Biological: Arterial blood sampling, Biological: Ultrafiltrate sampling, Device: CVVH using oXiris™ filter | Arm Label: CVVH using PrismafleX HF1400 filter; Type: ACTIVE_COMPARATOR; Interventions: Biological: Arterial blood sampling, Biological: Ultrafiltrate sampling, Device: CVVH using PrismafleX HF1400 filter | Intervention Type: BIOLOGICAL; Name: Arterial blood sampling; Assigned to Arm(s): CVVH using PrismafleX HF1400 filter, CVVH using oXiris™ filter | Intervention Type: BIOLOGICAL; Name: Ultrafiltrate sampling; Assigned to Arm(s): CVVH using PrismafleX HF1400 filter, CVVH using oXiris™ filter | Intervention Type: DEVICE; Name: CVVH using oXiris™ filter; Assigned to Arm(s): CVVH using oXiris™ filter | Intervention Type: DEVICE; Name: CVVH using PrismafleX HF1400 filter; Assigned to Arm(s): CVVH using PrismafleX HF1400 filter
B: Arm Label: heparin; Type: ACTIVE_COMPARATOR; Interventions: Other: regional anticoagulation with citrate | Arm Label: Citrate; Type: ACTIVE_COMPARATOR; Interventions: Other: HfCitPre | Intervention Type: OTHER; Name: regional anticoagulation with citrate; Assigned to Arm(s): heparin | Intervention Type: OTHER; Name: HfCitPre; Assigned to Arm(s): Citrate
C: Arm Label: RCA Group; Type: EXPERIMENTAL; Interventions: Drug: Anticoagulation to prevent clotting of the extracorporeal circuit. (regional citrate anticoagulation) | Arm Label: Heparin group; Type: EXPERIMENTAL; Interventions: Drug: Anticoagulation to prevent clotting of the extracorporeal circuit (Unfractionated heparin) | Intervention Type: DRUG; Name: Anticoagulation to prevent clotting of the extracorporeal circuit. (regional citrate anticoagulation); Assigned to Arm(s): RCA Group | Intervention Type: DRUG; Name: Anticoagulation to prevent clotting of the extracorporeal circuit (Unfractionated heparin); Assigned to Arm(s): Heparin group
D: Arm Label: Prismocitrate 18; Type: EXPERIMENTAL; Interventions: Drug: Prismocitrate 18 | Arm Label: No Regional Anticoagulation of CRRT Circuit; Type: ACTIVE_COMPARATOR; Interventions: Other: No Anticoagulation | Intervention Type: DRUG; Name: Prismocitrate 18; Assigned to Arm(s): Prismocitrate 18 | Intervention Type: OTHER; Name: No Anticoagulation; Assigned to Arm(s): No Regional Anticoagulation of CRRT Circuit

Answer: A