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

ESHOL Study 2011.

Methods

  • Study design: parallel RCT

  • Study time frame: May 2007 to October 2011

  • Duration of follow‐up: 3 years
Participants

  • Country: Spain

  • Setting: multi‐centre (27)

  • Patients aged ≥18 years; currently undergoing HD; clinical stability; stable vascular access

    • Mean time on dialysis ± SD (months): treatment group (47.4 ± 55); control group (50.3 ± 71)

    • Diabetes: treatment group (22.8%); control group (27.1)

  • Number: treatment group (456); control group (450)

  • Mean age ± SD (years): treatment group (64.56 ± 14.4); control group (66.36 ± 14.3)

  • Sex (M/F): treatment group (317/139); control group (289/161)

  • Exclusion criteria: chronic inflammatory diseases; liver cirrhosis; malignancies; chronic immunosuppressant or anti‐inflammatory use; dialysis through temporary catheter or single puncture
Interventions Treatment group

  • Post‐dilution on‐line HDF 3 times/week


Control group

  • HD 3 times/week


Both groups

  • The length of dialysis sessions in each treatment modality was not modified

  • For patients on post‐dilution HDF, a minimum of 18 L/session replacement volume was requested
Outcomes

  • Survival

  • Intradialysis tolerance (symptomatic hypotension episodes, cramps, headache, fatigue and thoracic pain)

  • Hospitalisations for any reason

  • Dialysis adequacy (time average concentration, Kt/V, URR, nutrition parameters)

  • BP control

  • Anaemia, lipid metabolism and phosphate control

  • B2 microglobulin reduction ratio
Notes

  • Exclusions post randomisation but pre‐intervention: 33

  • Stop or end point/s: not stated

  • Funding: this study was partly supported by grants from Fresenius Medical Care and Gambro Healthcare
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A central computerised random‐generator
Allocation concealment (selection bias) Unclear risk Centrally
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Open‐label study
Incomplete outcome data (attrition bias) 
 All outcomes High risk 355/906 discontinued the study, 39% from the total number of included patients, 41% in the HDF arm
Selective reporting (reporting bias) Low risk All the prespecified outcomes were reported
Other bias High risk Commercial sponsor on authorship or involved in data management; interventions and baseline patient characteristics not matched