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

Righetti 2010.

Methods

  • Study design: cross‐over RCT

  • Study time frame: not stated

  • Duration of follow‐up: 18 months
Participants

  • Country: Italy

  • Setting: multi‐centre (2)

  • Chronic HD patients, at least 2 months on dialysis, on a regular treatment with ESA (alpha epoetin), iron gluconate and vitamin B

    • Mean time on dialysis: 48.7 ± 9.9 months

  • Number: 24

  • Mean age ± SD: 61.4 ± 2.9 years

  • Sex (M/F): 16/8

  • Exclusion criteria: patients with residual renal function; severe CV disease (left ventricular ejection fraction less than 30% and/or a NYHA heart disease classification of III‐IV); malignancy; basal albumin < 4 mg/dl.
Interventions Treatment group

  • Internal HDF, high‐flux membrane TS1.8UL (Toraysulfone), treatments performed with the AK 200/200‐S ULTRA (Gambro), 3 sessions/week,

    • Mean blood flow: 326 ± 3 mL/min

    • Session length: 228 ± 22 min

    • Ultrafiltration volume: about 14 L/session


Control group

  • Low‐flux HD, low‐flux membrane BLS (Bellco, Italy) and Polyflux L (Gambro, Sweden); treatments performed with the AK 200/200‐S ULTRA (Gambro), 3 sessions/week

    • Mean blood flow: 335 ± 2 mL/min

    • Session length: 228 ± 22 min
Outcomes

  • Mean urea clearance (URR)

  • Urea Kt/V

  • End of treatment B2 microglobulin levels (mg/L) pre‐dialysis

  • Other biochemical measurements
Notes

  • Exclusions post randomisation but pre‐intervention: 4

  • Stop or end point/s: not stated

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

  • Funding: "None of the authors has any financial arrangements with any of the companies whose products were used in the study"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Centrally: "An independent person performed randomisation for the sequence of treatment. "
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Probably not done
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Probably not done
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Missing outcome data balanced across groups but no intention‐to‐treat analysis
Selective reporting (reporting bias) High risk Data for end of first phase of treatment not available; insufficient information, no study protocol available
Other bias High risk Carry over effect present because of the cross‐over design; interventions not matched