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

PROFIL Study 2011.

Methods

  • Study design: parallel RCT

  • Study time frame: May 2000 to September 2005

  • Duration of follow‐up: 2 years
Participants

  • Country: Sweden and Denmark

  • Setting: multi‐centre (10)

  • CKD stage 5; aged 18 to 80 years; on dialysis < 3 months

    • Mean time on dialysis: not stated

  • Number (randomised/analysed): 48/34; treatment group (?/18); control group (?/16)

  • Mean age ± SD (years): treatment group (62 ± 11); control group (64 ± 13)

  • Sex (M/F): 24/10

  • Exclusion criteria: MI within 3 months; well‐defined unstable angina; severe cardiac valvular disease; severe cardiac failure (NYHA III–IV); disseminated malignancy; expected HD treatment < 1 year; expected need of central venous catheter > 3 months; body weight > 100 kg; participation in other studies; patient not willing/not able to undergo examinations according to protocol
Interventions Treatment group

  • ∙ On‐line, predilution HF, 3 sessions/week, High‐flux/Polyflux H membrane, treatments performed with the AK 100/200 ULTRA (Gambro)

    • Mean blood flow: 325 ± 15 mL/min

    • Session length: 253 ± 4 min

    • Ultrafiltration volume: 38.5 ± 6 L/session


Control group

  • Low‐flux HD, 3 sessions/week, low‐flux membrane/Polyflux L (Gambro, Sweden), treatments performed with any HD machine

    • Mean blood flow 273 ± 6 mL/min

    • Session length 257 ± 6 min
Outcomes

  • All‐cause mortality

  • Intradialytic symptoms

  • Number of hospital admissions

  • Adequacy of dialysis, URR and urea Kt/V

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

  • End of treatment BP

  • Other changes in CV measurements (e.g. LVMi)

  • Other biochemical measurements
Notes

  • Exclusions post randomisation but pre‐intervention: not stated

  • Stop or end point/s: not stated

  • Additional data requested from authors: to be completed

  • Funding: commercial sponsorship
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "patients were randomised to treatment with either HF or HD using an online computer‐based program stratified by age and diabetes "
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 Low risk Echocardiograms read by an observer blinded to treatment
Incomplete outcome data (attrition bias) 
 All outcomes High risk Missing outcome data balanced across groups but attrition is 29%; randomised (48), analysed (34), finished the 24 months follow‐up (17, 35%)
Selective reporting (reporting bias) High risk Study protocol available (ISRCTN83264534) and all pre‐specified outcomes have been reported. All key patient outcomes not provided
Other bias High risk Commercial sponsor on authorship and/or involved in data management, interventions not matched