Trial document




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  DRKS00012407

Trial Description

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Title

Myoglobin Clearance in CVVHD and CVVHDF with regional citrate antiocoagulation

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Trial Acronym

CIMIC-2

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URL of the Trial

http://intensivmedizin.uniklinikum-leipzig.de/

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Brief Summary in Lay Language

Critical ill patients (e.g. sepsis, shock...) develope often acute renal injury. It`s not possible that the kidney detoxicate and keep up the fluid balance adequate. For that reason the blood is cleared by dialyses.
Addition of citric acid blocks the blood clotting in the dialysis without increasing the risk of bleeding complications in the body.
That trial compares if a new diaylsis filter (CVVHD-Emic) equally to the standard technique (CVVHDF) clean up particle with a middle molecule mass (myoglobin) from the blood. Both study groups get an anticoagulation with citric acid.

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Brief Summary in Scientific Language

Critical ill patients with indication for renal replacement therapy will be included.
They will be randomized in two groups with a 1:1 ratio. Group A will be treated with CVVHDF CiCa Ultraflux AV 1000S and group B with CVVHD CiCa Ultraflux EMiC2 (Fresenius medical care). A total number of 75 patients will be included.
We hypothesize, that CVVHD using the EMiC2–filter is at least as effective as CVVHDF using normal high cut-off filters in eliminating myoglobine using regional citrate anticoagulation.

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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

  •   DRKS00012407
  •   2017/05/23
  •   [---]*
  •   yes
  •   Approved
  •   293/16-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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Health Condition or Problem studied

  •   N17.01 -  [generalization N17.0: Acute renal failure with tubular necrosis]
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Interventions/Observational Groups

  •   Dialysis usingCVVHDF CiCa Ultraflux AV 1000S
  •   Dialysis using CVVHD CiCa Ultraflux EMiC2
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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

Myoglobin clearance after 1h, 6h, 12h, 24h and 48h.

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Secondary Outcome

Urea, Creatinin, β2 microglobulin , Il-6 and human albumin clearance after 1h, 6h, 12h, 24h and 48h.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/05/02
  •   70
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

inidcation for renal replacement therapy

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Exclusion Criteria

• Indication for therapeutic anticoagulation for different reasons
• Age < 18 years
• High risk of citrate accumulation (e.g. liver dysfunction)
• Contraindication for RRT (e.g. palliative situations)
• Refusal of the patient
• Moribund patient or high risk to die in the first 48 hours
• Pregnant and breast feeding women
• Inclusion in other studies

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Addresses

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    • Universitätsklinikum Leipzig AöR
    • Liebigstraße 18
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig AöR Interdisziplinäre Internistische Intensivmedizin Leiter: Prof. Dr. med. Sirak Petros
    • Dr. med.  Lorenz  Weidhase 
    • Liebigstraße 20
    • 04103  Leipzig
    • Germany
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    • Interdisziplinäre Internistische Intensivstation, Universitätsklinikum Leipzig
    • Mr.  Dr.med.  Lorenz  Weidhase 
    • Liebigstraße 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 v.d.H
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2018/09/30
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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.