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Cytokine Adsorption in Sepsis and Acute Kidney Injury (CASAKI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Technische Universität München
Sponsor:
Information provided by (Responsible Party):
Guenther_Edenharter, Technische Universität München
ClinicalTrials.gov Identifier:
NCT02588794
First received: October 27, 2015
Last updated: NA
Last verified: October 2015
History: No changes posted
  Purpose
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 Intervention
Renal Insufficiency or Renal Failure &or End-stage Renal Disease
Device: CytoSorb 300 ml device (3804606CE01)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cytokine Adsorption in Sepsis and Acute Kidney Injury

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

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

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

Estimated Enrollment: 124
Study Start Date: October 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02588794

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

Locations
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
Study Chair: Kochs Eberhard, Chairman Department of Anaesthsiology
  More Information

Responsible Party: Guenther_Edenharter, Dr.med., Technische Universität München
ClinicalTrials.gov Identifier: NCT02588794     History of Changes
Other Study ID Numbers: 316/15 S
Study First Received: October 27, 2015
Last Updated: October 27, 2015

Keywords provided by Technische Universität München:
sepsis, acute kidney injury , CytoSorb

Additional relevant MeSH terms:
Sepsis
Kidney Failure, Chronic
Renal Insufficiency
Acute Kidney Injury
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on March 28, 2017