Suspected or Diagnosed Endotoxemia Casued by Gram-negative Bacteria
Conditions
Brief summary
This registry will collect and validate regulatory-grade real-world data (RWD) on the usage of the LPS-Adsorber and the outcomes from using the LPS-Adsorber in various patient populations (various sub-registries) that also have suspected endotoxemia. This data can be then used in real-world evidence (RWE) generation. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.
Interventions
DEVICELPS Adsorber
LPS Adsorber, binding endotoxin caused by suspected or verified gram-negative bacteria.
Sponsors
Alteco Medical AB
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Weight \> 30 kilos Specific sub-registry criteria are possible.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the time needed to achieve patient stabilization from the time of treatment. | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes will be to document the change in a patient's symptoms of infection over time. | 30 days |
| Rate of complaints and incidents related to the medical device during the whole registry. | 30 days |
Outcome results
None listed