OVERALL CLINICAL INVESTIGATION DESIGN:~This is a multicentre, stratified, parallel, double-blinded, randomized, feasibility clinical investigation of the Alteco® LPS Adsorber.~Subjects will be enrolled in an adaptive fashion with up to two interim analyses, and the possibility of recruiting additional patients, in order to establish an indication of the feasibility of treating a target population of subjects with septic shock and endotoxemia.~Subjects will be stratified in accordance with the origin of their infection, i.e. abdominal or urogenital sepsis. Subjects in each stratum will receive either:~LPS Adsorber group (i.e. investigational medical device [IMD] group): current best practice in combination with Alteco® LPS Adsorber treatment, OR~Placebo device group (i.e. comparator group): current best practice in combination with placebo adsorber treatment.~Allocation to either treatment arm will be performed in a 1:1 ratio. Upon enrolment (i.e. pre-treatment phase), subjects admitted to the ICU with suspected endotoxemia will be screened for fulfilment of the Illness Severity Criteria confirming early stage severe sepsis.~Within six (6) hours of enrolment, subjects who also fulfil the Treatment Criteria confirming septic shock will be eligible for randomization.~Randomization to either of the treatment groups will be performed as close as possible to start of treatment with the Alteco® LPS Adsorber or placebo device.~Treatment with LPS Adsorber or placebo device must be initiated within six (6) hours (Day 1) following fulfilment of the Treatment Criteria. A second device treatment will be performed 24 hours after the end of the first device treatment on Day 2, as long there is no evidence that treatment with the investigational device will not be beneficial or will indicate an unnecessary risk for subjects (for example, the subject is vasopressor support-free).~Initially: 20 abdominal sepsis subjects (Stratum A) and 12 urogenital sepsis subjects (Stratum B) Optional: additional 12 subjects (abdominal, urogenital or both) after interim analysis decision.
The primary objective of this clinical investigation is to investigate the feasibility and possible benefits of the Alteco® LPS Adsorber in treating patients with septic shock with presumed endotoxemia of abdominal or urogenital origin.