Cytokine Adsorption in Sepsis and Acute Kidney Injury (CASAKI)

Technical University of Munich

Status: Unknown

Conditions: Renal Insufficiency or Renal Failure &or End-stage Renal Disease

Treatments: Device: CytoSorb 300 ml device (3804606CE01)

Study type: Interventional

Funder types: Other

Identifiers

NCT02588794

316/15 S

Details and patient eligibility

About

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

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

intervention

Active Comparator group

Description:

Standart CVVHD plus CytoSorb 300 ml device (3804606CE01)

Treatment:

Device: CytoSorb 300 ml device (3804606CE01)

control

No Intervention group

Description:

Standart CVVHD