Trial document




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  DRKS00005254

Trial Description

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Title

middle molecular clearance in citrate-based dialysis using a conventional vs. high-cutoff dialyzer

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Trial Acronym

CIMIC

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This prospective randomized trial should investigate, if a large-pored dialysator is superior in elimination of middle moleculs. Critical ill patients requiring dialysis caused by renal failure will be randomized in group A (conventional citrate anticoagulation) and group B (citrate anticoagulation and large-pored EMiC®2 dialyzer).

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Brief Summary in Scientific Language

This prospective and randomised study should investigate the clearance of middle molecules in CVVHD with regional citrate anticoagulation using conventional or large-pored EMiC®2-dialyzer .
Maybe the use of EMiC®2-dialyzer could aggregate the advantages of regional citrate anticoagulation and CVVH.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005254
  •   2013/11/26
  •   [---]*
  •   yes
  •   Approved
  •   447/12-24092012, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N17 -  Acute renal failure
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Interventions/Observational Groups

  •   CVVHD with regional citrate anticoagulation: therapy period: max. 72h, 5 blood samples ahead and after dialyzer
  •   CVVHD with regional citrate anticoagulation using large-pored EMiC®2-dialyzer: therapy period: max. 72h, 5 blood samples ahead and after dialyzer
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

β2-Mikroglobulin Clearance after 1 h, 6 h, 12 h, 24 h und 48 h (estimated by serum levels before and after dialyzer)

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Secondary Outcome

Clearance of Urea, Creatinin, Myoglobin and IL-6 after 1 h, 6 h, 12 h, 24 h und 48 h (estimated by serum levels before and after dialyzer)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/12/01
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

acute dialysis dependent renal failure

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Exclusion Criteria

therapeutic anticoagulation necessary in other indication; younger than 18 years; high risk of citrate accumulation (for instance acute liver failure); refusal of or contraindications for renal replacement therapie; predicted survival less than 48 h; pregnancy or lactation; member in other clinical trials; decline participation in study

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Addresses

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    • Universität Leipzig
    • Ritterstraße 26
    • 04109  Leipzig
    • Germany
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    •   [---]*
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    •   [---]*
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    • Universitätsklinikum Leipzig Department für Innere Medizin, Neurologie & Dermatologie Internistische Intensivmedizin
    • Mr.  Dr. med.  Lorenz  Weidhase 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig, DIND, Interdisziplinäre Internistische Intensivmedizin
    • Mr.  Dr.  Lorenz  Weidhase 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Fresenius Medical Care Deutschland GmbH
    • Else-Kröner-Straße 1
    • 61352  Bad Homburg
    • Germany
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    •   [---]*
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/05/31
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* This entry means the parameter is not applicable or has not been set.