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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Renal Insufficiency or Renal Failure &or End-stage Renal Disease | Device: CytoSorb 300 ml device (3804606CE01) | Not Applicable |
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 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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: intervention
Standart CVVHD plus CytoSorb 300 ml device (3804606CE01)
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Device: CytoSorb 300 ml device (3804606CE01)
additional cytokine adsorber |
No Intervention: control
Standart CVVHD
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- RIFLE stadium L or E after acute kidney injury related to sepsis [ Time Frame: 3 months ]
- 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 ]

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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

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
Contact: Ralph Bogdanski, MD | +498941405472 | ralph.bogdanski@tum.de | |
Contact: Barbara Kapfer, MD | +498941405473 | b.kapfer@tum.de |
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 |
Study Chair: | Kochs Eberhard, Chairman | Department of Anaesthsiology |
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 |
sepsis, acute kidney injury , CytoSorb |
Sepsis Acute Kidney Injury Kidney Failure, Chronic Renal Insufficiency Infection Systemic Inflammatory Response Syndrome |
Inflammation Pathologic Processes Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic |