Please select the eligibility criteria that correspond 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: Inclusion criteria: • Patients with septic shock, defined as 30ml/kg of i.v. fluid administered within a period of 6 hours after initiation of vasopressor therapy with a vasopressor index =3, and at least one of the following criteria: metabolic acidosis, neurologic dysfunction, renal dysfunction, or acute hepatic dysfunction

* Male and Female patients =18 years
* Endotoxin levels =0.6 IU EAA (measured at ICU admission and repeated 24 hours later in case the initial value is =0.4 and \<0.6)

Exclusion criteria: • Endotoxin levels \<0.6 IU EAA

* Pregnancy or breast feeding
* Neutropenia (circulating neutrophils \<500/µl)
* Pre-existing immune deficiencies or immune-suppressive therapy, especially corticosteroids
* Use of Vasopressin (Pitressin?)
* Organ transplantation within the last 12 months
* Terminally ill patients classified as "do not resuscitate"
* History of sensitivity to polymyxin B or to anticoagulant (heparin) HIT or allergy to heparin
* Need for extracorporeal membrane oxygenation (ECMO)
B: Inclusion Criteria:

* Need for hemodialysis in the ICU for at least one treatment
* No prior hemodialysis treatment in the ICU except continuous renal replacement therapy

Exclusion Criteria:

* Need for systemic anticoagulation with unfractionated or fractionated heparin, oral anticoagulants or intravenous anti-aggregants for other reasons
* Need for continued thrombolysis therapy within the 6 hours before inclusion
* Need for continued treatment with activated protein C (drotrecogin alfa) within the 12 hours before inclusion
* Need for continued treatment with intravenous anti-aggregants (abciximab, eptifabide) within 12 hours before inclusion
* Liver failure (acute and acute-on-chronic)
* Confirmed or suspected Heparin Induced Thrombocytopenia (HIT)
* Heparin allergies
* Severe uncorrected hypocalcemia (ionized calcium \< 0,8 mmol/l)
* Refusal of informed consent
C: Inclusion Criteria:

* acute renal failure requiring renal replacement therapy

Exclusion Criteria:

* (recent) bleeding or a suspicion of bleeding necessitating transfusion,
* need of therapeutic anticoagulation or
* (suspected) heparin-induced thrombocytopenia
D: Inclusion Criteria:

* Age 18 or older and able to sign consent (or surrogate).
* Must have been referred to the inpatient Nephrology consult service for evaluation of acute kidney injury (AKI).
* Expected survival of at least 48 hours.

Exclusion Criteria:

* Hemoglobin \< 8 g/dl
* Serum potassium ≥6.5 milliequivalents per liter (mEq/L)
* Weight \> 120kg.

Answer: A