Blood Compatibility Characteristics of Baxter Xenium+, Fresenius FX and Gambro Polyflux Dialyzers

NCT01273870 | Completed

• 1 other identifier: PDA-02
• Study Type: observational
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the dialyzer evaluation is to compare performance characteristics and haemocompatibility of the Baxter Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux dialyzers

Conditions

End Stage Renal Failure on Dialysis

Keywords

hemodialysis; high-flux-dialyzer; performance; blood compatibility

Outcome Measures

Primary Outcomes (1)

• Clearance for urea, phosphate, beta-2-microglobulin blood cell drop, complement factor C5a, TAT

  January 2011

Secondary Outcomes (1)

• General survey of the dialysis treatments

  January 2011

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

8 patients will undergo 1 treatment each with the 4 high-flux dialyzer types using a bloodflow of 300 ml/min, dialysate flow 500 ml/min and the dialysis machine Fresenius 5008

You may qualify if:

• ESRD patients 18 years or older
• Stable on hemodialysis for more than 3 months
• An average haematocrit value of 30 % or higher in the last three 3 months
• Stable vascular access of either a fistula or graft
• Stable anticoagulation and regimen
• Stable erythropoiesis-stimulating agent (ESA) regimen for the last three 3 months
• No active infection
• Able to sign informed consent and able to participate in the study
• Medically stable

You may not qualify if:

• Participation in another study which may interfere with the planned study
• Active infection
• Medical conditions which may interfere with the study (cardiac, liver disease, hepatitis)
• Female(s) who are pregnant or planning to be pregnant
• Problem with or allergy to anticoagulation
• Central venous catheters

Sponsors & Collaborators

• Praxisverbund Dialyse und Apherese: lead

Study Officials

• Roland E Winkler, PhD

  Praxisverbund fuer Dialyse und Apherese Rostock

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: January 11, 2011
• Study Start: December 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 2, 2011

Record last verified: 2010-11