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Cytokine Adsorption in Sepsis and Acute Kidney Injury (CASAKI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02588794
Recruitment Status : Unknown
Verified October 2015 by Guenther_Edenharter, Technische Universität München.
Recruitment status was:  Recruiting
First Posted : October 28, 2015
Last Update Posted : October 28, 2015
Information provided by (Responsible Party):
Guenther_Edenharter, Technische Universität München

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

Condition or disease Intervention/treatment Phase
Renal Insufficiency or Renal Failure &or End-stage Renal Disease Device: CytoSorb 300 ml device (3804606CE01) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cytokine Adsorption in Sepsis and Acute Kidney Injury
Study Start Date : October 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Active Comparator: intervention
Standart CVVHD plus CytoSorb 300 ml device (3804606CE01)
Device: CytoSorb 300 ml device (3804606CE01)
additional cytokine adsorber

No Intervention: control
Standart CVVHD

Primary Outcome Measures :
  1. RIFLE stadium L or E after acute kidney injury related to sepsis [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. mortality [ Time Frame: 3 months ]
  2. length of renal replacement therapy [ Time Frame: 3 months ]
  3. SOFA score [ Time Frame: 3 months ]
  4. cumulative dose of vasopressor support [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02588794

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Contact: Ralph Bogdanski, MD +498941405472
Contact: Barbara Kapfer, MD +498941405473

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Klinik für Anästhesiologie Recruiting
München, Bayern, Germany, 81675
Contact: Ralph Bogdanski, MD    +498941405472   
Contact: Barbara Kapfer, MD    +498941405473   
Principal Investigator: Markus Heim, MD         
Principal Investigator: Günther Edenharter, MD         
Sponsors and Collaborators
Technische Universität München
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Study Chair: Kochs Eberhard, Chairman Department of Anaesthsiology
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Responsible Party: Guenther_Edenharter,, Technische Universität München Identifier: NCT02588794    
Other Study ID Numbers: 316/15 S
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015
Keywords provided by Guenther_Edenharter, Technische Universität München:
sepsis, acute kidney injury , CytoSorb
Additional relevant MeSH terms:
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Acute Kidney Injury
Kidney Failure, Chronic
Renal Insufficiency
Systemic Inflammatory Response Syndrome
Pathologic Processes
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic