Trial document





This trial has been registered retrospectively.
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  DRKS00007928

Trial Description

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Title

Removal of cytokines during cardiac surgery

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Trial Acronym

RECCAS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

CytoSorb is novel device for extrcorporal haemoadsorption. In this study we try to assess if concentrations of inflammatory mediators can be reduced by intraoperative haemoadsorption with CytoSorb in patients undergoing cardiac surgery.
Furthermore, data of clinical outcomes are collected during ICU and hospital stay.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00007928
  •   2015/08/03
  •   [---]*
  •   yes
  •   Approved
  •   5094-14, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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Health Condition or Problem studied

  •   Postoperative inflammatory response
    Organ failure
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Interventions/Observational Groups

  •   Study group - Use of intraoperative haeoadsorption with CytoSorb
  •   Control group - Standard of care
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   No treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Reduction of IL6 by intraoperative haemoadsorption
(Time points: baseline, intraoperative, admission on ICU, day 1 and day 2)

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Secondary Outcome

- Length of ICU and hospital stay
- ICU and hospital mortality
- Number of complications (e. g. pneumonia, delirium, organ failure, infections, renal failure)
- Incidence of acute kidney injury (according to AKIN criteria)
- Duration of RRT
- SOFA-score
- Kinetics of different blood and urine markers (IL-6, IL-2, IL-8, IL-10, TNF-alpha, C3a, free haemoglobin, haptoglobin, myoglobin, fibrinogen
ICG-PDR, syndecan-1, heparan-sulphate and hyaluronan, [TIMP-2]x[IGFBP7])
Time points: baseline, intraoperative, admission on ICU, day 1 and day 2

- haemodynamics
(arterial pressure, heart rate, cardiac output, preload, syst. vascular resistance, extravascular lung water, doses of catecholamines)
Time points: baseline, intraoperative, admission on ICU, day 1 and day 2)

- duration of mechanical ventilation, respiratory function

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/01/26
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   no maximum age
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Additional Inclusion Criteria

- Adult patients > 65 years undergoing cardiac surgery with CPB-duration > 90 min
- Written informed consent

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Exclusion Criteria

- Age < 65 years
- Missing informed consent
- Planned CPB temperature < 32°C
- Emergency surgery
- Previous renal replacement therapy
- Preexisting kidney disease not requiring RRT (GFR < 30 mL/min)
- Prior kidney transplant
- Application of contrast medium on the day of surgery
- Immunosuppressive therapy or long-term therapy with corticosteroids
- Acute infective endocarditis
- AIDS with a CD4 count of < 200/µL
- Participation in another clinical intervention trial

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Addresses

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    • Universitätsklinikum Köln
    • Mr.  Dr. med.  Andreas  Hohn 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Universitätsklinikum Köln
    • Mr.  Dr. med.  Andreas  Hohn 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • BG Universitätsklinikum Bergmannsheil
    • Mr.  Dr. med.  Andreas  Baumann 
    • Bürkle-De-la-Camp Platz 1
    • 44789  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • CytoSorbents Europe GmbH
    • Bölschestraße 116
    • 12587  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.