Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006470

Trial Description

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Title

Impact of an Increased Sodium Chloride Concentration in the Infusion Fluid of Predilution Hemodiafiltration on the Removal of Protein-Bound Uremic Toxins

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

An increase of the free fraction may allow a better removal of of protein-bound uremic
toxins during dialysis. During predilution hemodiafiltration, the sodium chloride (NaCl)
concentration will be increased in the infusion fluid at a target NaCl concentration and the
effect on the removal of protein-bound toxins will be determined. Comparisons will be made
to standard hemodialysis and hemodiafiltration.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006470
  •   2015/04/24
  •   2013/08/10
  •   no
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Secondary IDs

  •   NCT01923961  (ClinicalTrials.gov)
  •   KSSA0113  (EXcorLab GmbH)
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Health Condition or Problem studied

  •   End-stage Renal Disease
  •   N18.5 -  Chronic kidney disease, stage 5
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Interventions/Observational Groups

  •   Drug: 5 M NaCl solution
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Crossover
  •   N/A
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Primary Outcome

- Plasma concentrations of para-cresylsulfate and indoxylsulfate; time frame: 4 hours; Determination of performance; calculation of removal ratios, clearances, and mass balances of protein-bound uremic toxins

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Secondary Outcome

- Plasma concentrations of NaCl; time frame: 4 hours; Measurement of NaCl concentrations over time to verify adequate NaCl balance

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/08/31
  •   8
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Inclusion Criteria

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

- End-stage renal disease

- Maintenance hemodialysis or hemodiafiltration for more than 3 months

- Stable clinical condition

- > 18 years

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Exclusion Criteria

- Life expectancy less than 1 year

- Pregnancy

- Active infectious disease

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Addresses

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    • EXcorLab GmbH
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    • University Hospital Würzburg
    • Detlef H Krieter, MD 
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    • Detlef H Krieter, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2015/10/22
* This entry means the parameter is not applicable or has not been set.