Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Effects of a Polyethyleneimine-coated Membrane (oXiris™) for Hemofiltration Versus Polymyxin B- Immobilized Fibre Column (Toraymyxin™) for Hemoperfusion on Endotoxin Activity and Inflammatory Conditions in Septic Shock- A Randomized Controlled Pilot Study
Brief Summary: Septic shock has a high mortality risk despite the availability of various treatments. Endotoxin, that is present in the cell walls of gram-negative bacteria, is a potent trigger of innate immunity. Endotoxin leads to an activation of a cascade with an overwhelming systemic overflow of pro- and anti- inflammatory mediators at the early phase of sepsis with generalized vascular endothelial damage, tissue injury and multi-organ failure.

Extracorporeal blood purification therapies aim to reduce the circulating level of endotoxin. Different extracorporeal blood purification systems are available. The oXiris™ device comprises a surface treated AN69 membrane capable to adsorb a large spectrum of plasma cytokines, such as IL-6 and HMGB1 protein. The positively charged inner surface of the membrane allows absorbing negatively charged bacterial products such as endotoxin. From an historical perspective, filters containing AN69-based membranes have been the most commonly used products for CRRT in the management of critically ill patients and a substantial volume of published data exist.

Another extracorporeal endotoxin removal therapy is the hemoperfusion with ToraymyxinTM (PMX) filter, which is a cartridge selectively removing blood endotoxin. PMX is composed of polymyxin B covalently bonded to polystyrene-derivative fibres. It is well known that the polarity of the polymyxin B antibiotic binds endotoxin and has bactericidal activity. Therefore, the rationale underlying extracorporeal therapy with PMX is to remove circulating endotoxin by adsorption.

* Trial with medical device


Options:
A: Arm Label: oXiris™ filter; Type: EXPERIMENTAL; Interventions: Device: oXiris™ filter | Arm Label: Toraymyxin Filter; Type: EXPERIMENTAL; Interventions: Device: Toraymyxin Filter | Arm Label: Standard of Care; Type: OTHER; Interventions: Device: Standard of Care | Intervention Type: DEVICE; Name: oXiris™ filter; Assigned to Arm(s): oXiris™ filter | Intervention Type: DEVICE; Name: Toraymyxin Filter; Assigned to Arm(s): Toraymyxin Filter | Intervention Type: DEVICE; Name: Standard of Care; Assigned to Arm(s): Standard of Care
B: Arm Label: Standard Anticoagulation; Type: ACTIVE_COMPARATOR; Interventions: Drug: Unfractionated heparin | Arm Label: Citrasate; Type: EXPERIMENTAL; Interventions: Drug: Citrasate | Intervention Type: DRUG; Name: Unfractionated heparin; Assigned to Arm(s): Standard Anticoagulation | Intervention Type: DRUG; Name: Citrasate; Assigned to Arm(s): Citrasate
C: Arm Label: hemofiltration at 4L/h; Type: ACTIVE_COMPARATOR; Interventions: Procedure: CVVH 4 to 2 L/h | Arm Label: hemofiltration at 2L/h; Type: ACTIVE_COMPARATOR; Interventions: Procedure: CVVH 2 to 4L/h | Intervention Type: PROCEDURE; Name: CVVH 4 to 2 L/h; Assigned to Arm(s): hemofiltration at 4L/h | Intervention Type: PROCEDURE; Name: CVVH 2 to 4L/h; Assigned to Arm(s): hemofiltration at 2L/h
D: Arm Label: Continuous Venovenous Hemofiltration; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Continuous Venovenous Hemofiltration (CVVH) | Arm Label: Continuous Venovenouos Hemodialysis; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Continuous Venovenous Hemodialysis (CVVHD) | Intervention Type: PROCEDURE; Name: Continuous Venovenous Hemofiltration (CVVH); Assigned to Arm(s): Continuous Venovenous Hemofiltration | Intervention Type: PROCEDURE; Name: Continuous Venovenous Hemodialysis (CVVHD); Assigned to Arm(s): Continuous Venovenouos Hemodialysis

Answer: A