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

Ohtake 2012.

Methods

  • Study time frame: May 2007 to 2008

  • Study design: parallel RCT

  • Duration of follow‐up: 1 year
Participants

  • Country: Japan

  • Setting: single centre

  • CKD stage 5; aged 18 to 80 years; on dialysis < 6 months

    • Mean time on dialysis (months): treatment group (64.5 ± 38.2); control group (58.8 ± 64.4)

  • Number: treatment group (13); control group (9)

  • Mean age ± SD (years): treatment group (58.6 ± 11.3); control group (62.4 ± 7.7)

  • Sex (M/F): 15/7

  • Exclusion criteria: acute infection or hospitalizations within 4 weeks before study entry; functional failure of arteriovenous fistula with less than 5 mL/kg/min or more blood flow; malignancy, pregnancy, severely suppressed cardiac function (EF < 40%) and/or severe arrhythmia, and dialysis difficulty due to unstable intradialytic blood pressure status.
Interventions Treatment group

  • On‐line, predilution HDF

    • High‐flux/Polyflux H membrane, treatments performed with the APSEx, Asahi Kasei Kuraray Medical Co. Ltd, Tokyo, Japan


Control group

  • High‐flux HD

  • High‐flux/Polyflux H membrane, treatments performed with the APSEx, Asahi Kasei Kuraray Medical Co. Ltd, Tokyo, Japan
Outcomes

  • Left ventricular systolic and diastolic functional markers

  • Pulse wave velocity

  • Ankle‐brachial pressure index and intima‐media thickness of carotid artery

  • Adequacy of dialysis, mean urea Kt/V

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

  • End of treatment blood pressure

  • 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

  • Funding: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number table
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; insufficient information provided about losses to follow‐up
Selective reporting (reporting bias) High risk Data about mortality events were missing
Other bias Low risk No additional risks identified