Wednesday, November 25, 2015 11:05:34 AM
I couldn't find this trial on the ClinicalTrials.gov site so I assume this hasn't been reported on the board yet. The DRKS is an open access online register for clinical trials conducted in Germany and is an approved Primary Register in the WHO network and is an accepted registry by the International Committee of Medical Journal Editors (ICMJE).
DRKS-ID: DRKS00007928
Title: Removal of cytokines during cardiac surgery (RECCAS)
Summary: CytoSorb is novel device for extrcorporal haemoadsorption. In this study we try to assess if concentrations of inflammatory mediators, such as IL6, can be effectively reduced by intraoperative haemoadsorption with CytoSorb in patients undergoing on-pump cardiac surgery. Secondary, kinetics of other markers of inflammation, organ dysfunction or glycocalix-shedding are evaluated. Furthermore, data on clinical outcomes, such as mortality, length of stay, duration of mechanical ventilation, delirium, infection, and organ dysfunction are collected during ICU and hospital stay.
Date of Registration in DRKS: 2015/08/03
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 5094-14, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
Health Condition or Problem studied: Postoperative inflammatory response Organ failure
Interventions/Observational Groups
Arm 1: Study group - Use of intraoperative haeoadsorption with CytoSorb
Arm 2: Control group - Standard of care
Countries of Recruitment: DE: Germany
Locations of Recruitment: University Medical Center Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Bochum
(Anticipated or Actual) Date of First Enrollment: 2015/01/26
Planned/Actual: Actual
Target Sample Size: 40
Monocenter trial, National
Primary Sponsor: Universitätsklinikum Köln, Dr. Andreas Hohn
Recruitment Status: Recruiting ongoing
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