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Cytokine Adsorption in Sepsis and Acute Kidney Injury (CASAKI)

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Guenther_Edenharter, Technische Universität München

Study Description
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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.

Study Design
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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

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02588794


Contacts
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Contact: Ralph Bogdanski, MD +498941405472 ralph.bogdanski@tum.de
Contact: Barbara Kapfer, MD +498941405473 b.kapfer@tum.de

Locations
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Germany
Klinik für Anästhesiologie Recruiting
München, Bayern, Germany, 81675
Contact: Ralph Bogdanski, MD    +498941405472    ralph.bogdanski@tum.de   
Contact: Barbara Kapfer, MD    +498941405473    b.kapfer@tum.de   
Principal Investigator: Markus Heim, MD         
Principal Investigator: Günther Edenharter, MD         
Sponsors and Collaborators
Technische Universität München
Investigators
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Study Chair: Kochs Eberhard, Chairman Department of Anaesthsiology
More Information
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Responsible Party: Guenther_Edenharter, Dr.med., Technische Universität München
ClinicalTrials.gov 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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Sepsis
Acute Kidney Injury
Kidney Failure, Chronic
Renal Insufficiency
Infection
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic