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. 2015 May 20;2015(5):CD006258. doi: 10.1002/14651858.CD006258.pub2

Bammens 2004.

Methods

  • Study design: cross‐over RCT

  • Study time frame: not stated

  • Duration of follow‐up: 2 weeks
Participants

  • Country: Germany

  • Setting: single centre

  • Stable chronic HD patients

    • Mean time on dialysis: 24.8 months

  • Number: 14

  • Sex (M/F): 10/4

  • Mean age ± SD: 66.6 ± 3.1 years

  • Exclusion criteria: not stated
Interventions Treatment group 1

  • HDF with replacement solution at 40, 60, 80 and 100 mL/min in a post‐dilution mode


Treatment group 2

  • HDF with replacement solution at 80 mL/min in pre‐dilution mode


Both treatment groups

  • Duration of each session: 4 hours

  • Dialyser: Fresenius F80

  • QD: 600 mL/min

  • QB: 300 mL/min

  • HDF with replacement solution at 120 mL/min in post‐dilution mode, with a QB of 350 mL/min and an QD of 800 mL/min was also studied in 6 patients, 2 sessions each


Control group

  • HD high‐flux

    • Duration of each session: 4 hours

    • Dialyser: Fresenius F80

    • QD: 600 mL/min

    • QB: 300 mL/min

  • HD with a QB of 350 mL/min and an QD of 800 mL/min was also studied in 6 patients, 2 sessions each


Co‐interventions: NS
Outcomes

  • B2 microglobulin reduction ratio

  • URR
Notes

  • Additional data requested from authors: method of randomisation; details regarding blinding

  • Funding: "Supported in part by the Fonds voor Wetenschappelijk Onderzoek (FWO) grant no. 1127602N; FX80 dialyzers were provided by Fresenius Medical Care, Bad Homburg, Germany."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not stated; probably not done
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Not stated; probably not done
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No data about drop‐outs provided after different cross‐over phases; lost to follow‐up: 0/14
Selective reporting (reporting bias) High risk Data at the end of first phase of treatment not available
Other bias High risk Carryover effect present because of the cross‐over design; data not extractable for meta‐analysis