A41.8 R57.2
Conditions
Interventions
Group 1: Combined therapy with cytokine eliminating hemofiltration using the Selecticure L19 filter and granulocyte/monocyte adsorption with the Immuloc®-sorbent adsorber, continuously during a total
Sponsors
eXcorLab GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: - Severe sepsis or septic shock, - Acute, septic renal failure and indication for renal replacement therapy, - Age =18 years, - Written informed consent of the patient or next of kin or legally authorized person
Exclusion criteria
Exclusion criteria: - Pregnant or breast-feeding women, - Age > 90 years, - bleeding risk due to underlying disease or recently performed surgery, - known allergies to components of the extracorporeal therapy, - Contraindications to heparin for anticoagulation including heparin induced thrombocytopenia Type II - previous severe sepsis during the hospital stay (“re-Sepsis”), - very poor prognosis (life expectancy < 6 months) due to concomitant disease (except severe sepsis or septic shock), - Aplasia, - currently on chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality at day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality at day 28 2. Length of stay on Intensive Care Unit 3. median SOFA- and APACHE II- (Sub-)Scores after 5 and 28 days 4. Length of stay in Hospital after study start 5. Daily urine output 6. Length of anuria until hospital dismission 7. Frequency and length of ventilator therapy until day 28 8. Vasopressor drug requirements until day 28 9. Length of renal replacement therapy until day 90 10. Course of defined laboratory parameters 11. Feasability of study therapy / study targets | — |
Countries
Germany
Contacts
Public ContactChristoph Sauvant
eXcorLab GmbH
Outcome results
None listed