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NCT Number: NCT00976846

Investigation of Performance and Compatibility of the Baxter Dialyzer Xenium XPH 210 During On-line Hemodiafiltration

The proposed study seeks to determine the appropriate balance between the removal of undesirable small molecular substances (urea, creatinine, phosphate) and large molecular substances (ß2-m) and the retention of important substances (e.g.albumin) for the Baxter Xenium XPH dialyzer type under defined therapeutic conditions of olHDF primarily concerning filtration flow rates in relation to blood flow/plasma water flow rates. Furthermore the possibility of the removal of certain protein-bound substances shall be investigated together with the impact of increasing ultrafiltration on the parameters of the micro-inflammation.

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Key information

About this study

The new high flux dialyser membrane Xenium XPH 210 from Baxter will show an considerably increased removal of ß2-Microglobulin with olHDF in post dilution mode together with a markedly increased removal of small molecules (urea, creatinine, phosphate). The loss of albumin will depend on the treatment modalities. However, the albumin permeability is tolerable over the whole range of total filtration rate selected and applied to the patients.

Together with the albumin loss into the filtrate/dialysate a small amount of albuminbound substances is detectable.

Parameters of micro-inflammation can be influenced by an increasing convective part of the treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have signed an informed consent form.
  • Patients between 18 and 75 years.
  • Patients who have been treated with hemodialysis for more than three months.
  • Patients who are treated three times a week for 4-5 hours.
  • Patients who are usually treated with high-flux dialyzers.
  • Patients who are on a stable anticoagulation and erythropoetin regimen.
  • Patients whose hematocrit is over 28 %.
  • Patients having no vascular access related problems.

Exclusion criteria

  • Patients not meeting the inclusion criteria.
  • Patients who are in a poor nutritional status as judged by the investigator.
  • Patients in a gravid state.
  • Patients with an unstable clinical condition (e.g. cardiac or vascular instability).
  • Patients whose life expectancy is less than 12 months.
  • Patients with a positive anamnesis for the first use syndrome.
  • Patients with known coagulation problems.
  • Patients who receive hemodialysis via a single dialysis needle or central venous catheter.
  • Patients participating in another study that may interfere with the outcome of the present study.

Treatment and study plan

Dialyzer Baxter Xenium XPH 210

Device

High-Flux dialyzer

Other names: Baxter Xenium XPH 210

Primary outcomes

  1. Concentration of urea, creatinine, phosphate and ß2-m (pre/post treatment in blood), concentration of albumin (pre/post treatment in blood and dialysate), hematocrit pre/post treatment (for correction of the impact of ultrafiltration on concentrations)

    Time frame: 3 weeks

Secondary outcomes

  1. Pre and post treatment: CMPF (metabolite of furan fatty acids), p-cresol, albumin binding capacity (ABIC) in blood and dialysate, pre and post treatment: IL-6, IL-1ß, sVCAM-1, sICAM-1, CD14+/CD16+, CD62L+, CD11b+ in blood

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Praxisverbund Dialyse und Apherese

Other

Registry information

Official study title

Clinical Study Investigating the Performance and Compatibility Characteristics of the Baxter Hollow Fiber Dialyzer Xenium XPH 210 During On-line Hemodiafiltration

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 15, 2009
Registry last updated
Sep 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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