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

Bolasco 2003.

Methods
  • Study design: parallel RCT

  • Study time frame: 2003 to 2008

  • Duration of follow‐up: 1.5 years; median 0.8 to 2.2

Participants
  • Country: Italy

  • Setting: multi‐centre

  • Chronic HD patients on dialysis for at least 6 months; aged 18 to 80 years; thrice‐weekly HD or HDF; body weight ≤ 90 kg

    • Mean time on dialysis: 3.0 (1.4 to 7.7) years

  • Number: 146

  • Age: Mean 67.4 years

  • Sex (M/F): 84/62

  • Exclusion criteria: malignancies, active systemic disease, active hepatitis or cirrhosis, instable diabetes, diuresis >200 mL/24 h, dysfunction of vascular access, with blood flow rate < 300 mL/min; clinically relevant infections, active systemic diseases

Interventions Treatment group 1
  • HF with high‐flux polyamide dialysers

    • Infusate/blood flow ratio of 0.6

    • Dialysate infusate rate of 700 mL/min


Treatment group 2
  • HDF with high‐flux polyamide dialysers

    • Infusate/blood flow ratio of 0.6

    • Dialysate infusate rate of 700 mL/min


Control group
  • HD with low‐flux dialysers

    • Dialysate flow rate of 500 mL/min

Outcomes
  • BP control

  • Intradialytic symptomatic hypotension

  • Mortality

  • Kt/V

Notes
  • Exclusions post randomisation but pre‐intervention: 10 patients

  • Stop or end point/s: not stated

  • Additional data requested from authors: none

  • Funding source: "We thank Gambro‐Hospal for the logistic support given to the investigator meetings."

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Central computer generated: " randomisation list that was stratified by centre and prepared in advance by one author"
Allocation concealment (selection bias) Unclear risk Patients were centrally randomised using an email assignment from one of the authors
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No blinding
Incomplete outcome data (attrition bias) 
 All outcomes High risk 10/146 (14%) withdrew from study due to transfer to another technique, thrombosis or vascular access infection, withdrawal of consent, transfer to another centre, transfer to another study, infection)
Selective reporting (reporting bias) High risk Key patient relevant outcomes not reported
Other bias High risk Interventions and patient characteristics not matched; industry support provided