Cytokine Adsorption in Sepsis and Acute Kidney Injury

Renal Insufficiency or Renal Failure &or End-stage Renal Disease Clinical Trial

— CASAKI  

Official title:

Cytokine Adsorption in Sepsis and Acute Kidney Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02588794
• Other study ID #: 316/15 S
• Status: Recruiting
• Phase: N/A
• First received: October 27, 2015
• Last updated: October 27, 2015
• Start date: October 2015
• Est. completion date: December 2017

Study information

• Verified date: October 2015
• Source: Technische Universität München
• Contact: Ralph Bogdanski, MD
• Phone: +498941405472
• Email: ralph.bogdanski[@]tum.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency or Renal Failure &or End-stage Renal Disease

Intervention

Device:
• CytoSorb 300 ml device (3804606CE01)
additional cytokine adsorber

Locations

Country	Name	City	State
Germany	Klinik für Anästhesiologie	München	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RIFLE stadium L or E after acute kidney injury related to sepsis		3 months	No
Secondary	mortality		3 months	No
Secondary	length of renal replacement therapy		3 months	No
Secondary	SOFA score		3 months	No
Secondary	cumulative dose of vasopressor support		4 weeks	No