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

Meert 2009.

Methods

  • Study design: cross‐over RCT

  • Study time frame: not stated

  • Duration of follow‐up: 9 weeks
Participants

  • Country: Belgium

  • Setting: single centre

  • Chronic HD patients on dialysis for at least 6 months, age 18 to 85, clinically stable, at least one month on high‐flux HD, vascular access with blood flow rate ≥ 300 mL/min

    • Mean time on dialysis: 30.2 ± 36.0 months

  • Number (randomised/analysed): 17/14

  • Mean age ± SD: 63.5 ± 17.7 years

  • Sex (M/F): 7/7

  • Exclusion criteria: expected survival < 1 year; expected transplant < 1 year; infectious disease; pregnancy; chronic inflammation; treated with single needle; treated with HDF or low‐flux HD; expected intradialytic body weight gain ≥ 4 kg
Interventions Treatment group

  •  Predilution HDF

    1. Dialysis machine AK 200 ULTRA S (Gambro, Sweden)

    2. High‐flux filters Polyflux 170 (Gambro, Lund, Sweden)


Control group 1

  • Predilution HF

    1. Dialysis machine AK 200 ULTRA S (Gambro, Sweden)

    2. High‐flux filters Polyflux 210 (Gambro, Lund, Sweden)


 Control group 2

  • Post dilution HDF

    • Not included in our analysis as no random allocation was described 
Outcomes

  • B2 microglobulin clearance

  • B2 microglobulin reduction ratio (%)

  • Other biochemical measurements
Notes

  • Exclusions post randomisation but pre‐intervention: not stated

  • Stop or end point/s: 1 patient due to lack of compliance

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

  • Funding: this study was supported by Gambro Corporate and one of the authors is an employee of Gambro Corporate
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 Insufficient information. probably not done
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Insufficient information. probably not done
Incomplete outcome data (attrition bias) 
 All outcomes High risk Missing outcome data; loss to follow‐up 3/17 (18%) (transplantation (2); lack of compliance (1))
Selective reporting (reporting bias) High risk Data for end of first phase of treatment not available
Other bias High risk Carry over effect present because of the cross‐over design; in the reported results is included a comparison between random and non‐randomly allocated groups; commercial sponsor involved in authorship or data management