Cytokine Adsorption in Sepsis and Acute Kidney Injury
- Conditions
- Renal Insufficiency or Renal Failure &or End-stage Renal Disease
- Interventions
- Device: CytoSorb 300 ml device (3804606CE01)
- Registration Number
- NCT02588794
- Lead Sponsor
- Technical University of Munich
- Brief Summary
Aim of the study is to reduce the incidence of RIFLE stadium L and E after acute kidney injury in patients with severe sepsis/septic shock
- Detailed Description
Patient with proved severe sepsis/septic shock, treated in accordance to actual sepsis guidelines, who develope akute kidney injury (RIFLE I) or kidney failure (RIFLE F), were randomized in two groups.
One group is treated with CVVHD/ local citrat anticoagulation (standart clinical practice).
The other group ist treated with an additional cytokine adsorber ( 300ml CytoSorb device, 3804606CE01)
CytoSorb therapy is performed for 24h, then the adsorber is changed into a new device.
Cytosorb therapy is stopped, when Interleukin 6 leves drop below 1000 pg/ml in patient serum.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 124
- severe sepsis or septic shock according to ESICM guidelines not older than 24 h
- preexisting renal disease KDIGO stadium 4 and 5
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention CytoSorb 300 ml device (3804606CE01) Standart CVVHD plus CytoSorb 300 ml device (3804606CE01)
- Primary Outcome Measures
Name Time Method RIFLE stadium L or E after acute kidney injury related to sepsis 3 months
- Secondary Outcome Measures
Name Time Method SOFA score 3 months length of renal replacement therapy 3 months mortality 3 months cumulative dose of vasopressor support 4 weeks
Trial Locations
- Locations (1)
Klinik für Anästhesiologie
🇩🇪München, Bayern, Germany