Cytokine Adsorption in Sepsis and Acute Kidney Injury

Not Applicable

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

• 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.

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-27
• Last Update Submitted: 2015-10-27
• Study First Posted: 2015-10-28
• Last Update Posted: 2015-10-28
• Primary Completion: 2017-08
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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