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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: intervention
Standart CVVHD plus CytoSorb 300 ml device (3804606CE01)
Device: CytoSorb 300 ml device (3804606CE01)
additional cytokine adsorber
No Intervention: control
- 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 ]
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, MDemail@example.com|
|Contact: Barbara Kapfer, MDfirstname.lastname@example.org|
|Klinik für Anästhesiologie||Recruiting|
|München, Bayern, Germany, 81675|
|Contact: Ralph Bogdanski, MD +498941405472 email@example.com|
|Contact: Barbara Kapfer, MD +498941405473 firstname.lastname@example.org|
|Principal Investigator: Markus Heim, MD|
|Principal Investigator: Günther Edenharter, MD|
|Study Chair:||Kochs Eberhard, Chairman||Department of Anaesthsiology|