Skip to main content
. 2015 May 20;2015(5):CD006258. doi: 10.1002/14651858.CD006258.pub2

Basile 2001.

Methods
  • Study design: cross‐over RCT

  • Study time frame: NS

  • Duration of follow‐up: 6 months/phase

Participants
  • Country: Italy

  • Setting: single centre

  • HD patients aged 18 to 75 years; routine use of EPO with no change in the 3 months preceding enrolment; rHuEPO dosage: < 120 IU/Kg/wk and EPO resistance index, 10 IU/kg/wk of Hb in the 3 months preceding enrolment; assurance from patients not to use EPO during the study; maintenance bicarbonate dialysis thrice‐weekly for at least 6 months previously with a cellulose dialyser; dialysis dosage > 1.2 of equilibrated single‐pool Kt/V; negligible residual renal function; no change in iron, folic acid, vitamin B12 or ACEi in the 3 months preceding the study

    • Mean time on dialysis: 53.2 months

  • Number (eligible/randomised/analysed): 23/15/10

  • Mean age: 59.9 ± 7.2 years

  • Gender (M/F): 6/4

  • Exclusion criteria: unstable conditions in the 3 months prior to the study; treatment with drugs affecting erythropoiesis; blood transfusion in the 3 months preceding enrolment

Interventions Treatment group
  • Thrice weekly AFB with AN69 dialyser

    • Post‐dilution infusion at a rate of 2L/h

    • QB: approximately 300 mL/min

    • QD: approximately 500 mL/min

    • Infusion rate: 2 L/h

    • Duration: 6 months (run‐in period: 4 months)


Control group
  • Thrice‐weekly, low‐flux HD with cellulose acetate membrane

    • QB: approximately 300 mL/min

    • QD: approximately 500 mL/min

    • Duration: 6 months (run‐in period: 4 months)


Co‐interventions: NS
Outcomes
  • Kt/V

  • Mortality

Notes
  • Exclusions post randomisation but pre‐intervention: not stated

  • Stop or end point/s: not stated

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

  • 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; probably not done
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not stated; probably not done
Incomplete outcome data (attrition bias) 
 All outcomes High risk 33% loss to follow‐up (5/15 patients whose Hb dropped at monthly checks were withdrawn from the study)
Selective reporting (reporting bias) High risk Data at the end of first phase of treatment not available
Other bias High risk Carry over effect present because of the cross‐over design; data not available for meta‐analysis