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

Wizemann 2000.

Methods
  • Study design: parallel RCT

  • Study time frame: not stated

  • Duration of follow‐up: 48 months

Participants
  • Country: Germany

  • Setting: single centre

  • Chronic HD patients on dialysis with low‐flux HD for at least 3 months

  • Number: treatment group (23); control group (21)

  • Mean age ± SD (years): treatment group (61 ± 12); control group (60 ± 11)

  • Sex (M/F): treatment group (12/11); control group (13/8)

  • Exclusion criteria: not stated

Interventions Treatment group
  • HDF with high‐flux polysulfone (Fresenius F‐80S) membranes for 24 months

    • QD: 100 to 200 mL/min

    • Duration of each dialysis session: 4.5 hours

    • Total substitution fluid volume was targeted to 60 L/session


Control group
  • HD with low‐flux polysulfone (Fresenius F8) membranes for 24 months

    • QB: 400 to 500 mL/min

    • QD: 500 mL/min

    • Dialysis duration: 4.5 hours


Co‐interventions: not stated
Outcomes
  • B2 microglobulin reduction ratio

  • URR

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; raw data for B2 microglobulin values

  • Funding: sponsor involved in authorship and/or data management

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 High risk 18% loss to follow‐up
Selective reporting (reporting bias) High risk Study protocol unavailable and outcomes of interest reported incompletely, cannot be used in meta‐analysis (e.g. BP)
Other bias High risk Sponsor involved in authorship and/or data management; interventions not matched

ACEi ‐ angiotensin‐converting enzyme inhibitor; AFB ‐ acetate‐free biofiltration; BD ‐ conventional bicarbonate dialysis; BP ‐ blood pressure; CKD ‐ chronic kidney disease; CrCl ‐ creatinine clearance; CV ‐ cardiovascular; EPO ‐ erythropoietin; ESKD ‐ end‐stage kidney disease; Hb ‐ haemoglobin; HCT ‐ haematocrit; HD ‐ haemodialysis; HF ‐ haemofiltration; HDF ‐ haemodiafiltration; HTN ‐ hypertension; LVMi ‐ left ventricular mass index; MAP ‐ mean arterial pressure; MI ‐ myocardial infarction; QB ‐ blood flow rate; QD ‐ dialysate flow rate; QoL ‐ quality of life; rHuEPO: recombinant human EPO; RRT ‐ renal replacement therapy; TIA ‐ transient Ischaemic attack; URR ‐ urea reduction ratio