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

Ding 2002.

Methods
  • Study design: cross‐over RCT

  • Study time frame: not stated

  • Duration of follow‐up: 12 months

Participants
  • Country: Italy

  • Setting: single centre

  • Stable maintenance HD patients

    • Mean duration on dialysis: 83.5 months

  • Number: 12

  • Sex (M/F): 8/4

  • Mean age ± SD: Mean 49.7 ± 11.3 years

  • Exclusion criteria: not stated

Interventions Treatment group
  • HDF treatments carried out using F‐60s high‐flux polysulfone dialysers

    • QB: 250 mL/min

    • QD: Pre‐dilution 620 mL/min, post‐dilution 720 to 740 mL/min

    • Infusion flow rate: pre‐dilution 180 mL/min, post‐dilution 60 to 80 mL/min


Control group
  • AFB was buffer free and acidosis was corrected with a 166 mEq/L sodium bicarbonate solution as the substitution fluid

    • QD: 500 mL/min

    • Infusion fluid rate: 25 to 30 mL/min


Co‐interventions: not stated
Outcomes
  • URR

  • B2 microglobulin reduction rate

Notes
  • Exclusions post randomisation: 3 patients violated the study protocol

  • Stop or end point/s: not stated

  • Additional data requested from authors: none requested

  • Funding: not stated

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 Unclear risk Not stated
Blinding of outcome assessment (detection bias) 
 All outcomes High risk "A second patient refused to finish post‐HDF and insisted that AFB be tried because of his unbearable shoulder"
Incomplete outcome data (attrition bias) 
 All outcomes High risk No intention‐to‐treat analysis; 3 patients violated the study protocol (one patient's fistula failed during the second month of pre‐HDF; one refused to finish post‐HDF; one patient had severe headache
 accompanied by poorly controlled hypertension at the end of pre‐HDF shift and dropped out of the
 study before starting post‐HDF modality)
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