Renal Insufficiency or Renal Failure &or End-stage Renal Disease
Conditions
Keywords
sepsis, acute kidney injury , CytoSorb
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.
Interventions
DEVICECytoSorb 300 ml device (3804606CE01)
additional cytokine adsorber
Sponsors
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* severe sepsis or septic shock according to ESICM guidelines not older than 24 h
Exclusion criteria
* preexisting renal disease KDIGO stadium 4 and 5
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RIFLE stadium L or E after acute kidney injury related to sepsis | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| mortality | 3 months |
| length of renal replacement therapy | 3 months |
| SOFA score | 3 months |
| cumulative dose of vasopressor support | 4 weeks |
Countries
Germany
Contacts
Primary ContactRalph Bogdanski, MD
Backup ContactBarbara Kapfer, MD
Outcome results
None listed