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

Todeschini 2002.

Methods
  • Study design: cross‐over RCT

  • Study time frame: not stated

  • Duration of follow‐up: 3 dialysis sessions

Participants
  • Country: Italy

  • Setting: single centre

  • Stable patients on HD 3 times/week; HCT > 30%; informed consent

  • Number: 9

  • Age: Mean 63.6 ± 7.2 years

  • Sex (M/F): 3/6

  • Exclusion criteria: uncontrolled hypertension (diastolic BP > 100 mm Hg); clinical evidence of unstable angina pectoris; on drugs known to affect haemostasis; evidence of acute illness or neoplasia

Interventions Treatment group
  • AFB with a biocompatible high‐flux polyacrylonitrile (AN69) membrane for 3 sessions

    • QB: 300 mL/min

    • QD: 500 mL/min

    • Duration of each dialysis session: 240 min


Control group
  • Bicarbonate HD with a biocompatible high‐flux polyacrylonitrile membrane (AN69) membrane

  • QB: 300 mL/min

  • QD: 500 mL/min

  • Duration of each dialysis session: 240 min


Co‐interventions: not stated
Outcomes
  • Kt/V

  • Pre‐ and post‐dialysis systolic BP

  • Difference between pre‐ and post‐dialysis systolic BP

  • Pre‐ and post‐dialysis diastolic BP

  • Difference between pre‐ and post‐dialysis diastolic BP

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: none 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 Unclear risk Not stated
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unclear; no loss to follow‐up
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; data not extractable for meta‐analysis