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. 2019 Jan 16;2019(1):CD011204. doi: 10.1002/14651858.CD011204.pub2

Daugirdas 1985.

Methods
  • Study design: cross‐over RCT

  • Duration of study: not reported

  • Duration of follow‐up: 4 weeks

Participants
  • Country: USA

  • Setting: single centre

  • Prevalent (on HD for > 1 year) HD patients (clinical characteristics not reported other than being prone to intradialytic hypotension and cramps and not clinically fluid overloaded)

  • Number: 10 patients allocated to control and then treatment, or treatment and then control, attrition of 3 patients for hospitalisation due to treatment‐unrelated illness, resulting in 7 for final analysis

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Mean time of dialysis: not reported

  • Exclusion criteria: not reported

Interventions HD regimen
  • 3 times/week, 4 hours/session

  • Low‐flux 1.0 m2 PAN plate dialysers

  • Acetate‐buffered dialysate

  • QB 250 mL/min, QD 500 mL/min, URR and Kt/V not reported


Treatment group 1
  • Dialysate [Na+]: 135 mM


Treatment group 2
  • Dialysate [Na+]: 143 mM


Treatment group 3
  • Profiled dialysate [Na+] from 160 to 133 mM (average dialysate [Na+] for session = ??, data not used)


Duration
  • 4 weeks for each (only the last 3 weeks of any given 4‐week block was analysed) (63 HD sessions in control group, 63 in treatment group)

Outcomes
  • Outcomes were assessed over the entire period of treatment/observation

    • Intradialytic hypotension ‐ "15% fall in mean arterial BP"

    • Predialysis SBP and DBP

    • Intradialytic SBP and DBP

    • Intradialytic cramps

    • IDWG

    • Thirst (VAS)

    • Predialysis serum [Na+]

    • Weakness score

Notes
  • Funding source: not reported

  • Extra information was requested from the authors but the original study data have been lost

  • Weakness scores were not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation clearly stated in published article, but not mechanism of randomisation
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double blinding clearly stated in published article and confirmed by the lead author
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 3 patient dropouts "were judged to be treatment‐unrelated, and accordingly, their data were excluded from analysis". The study is not analysed as intention to treat, and data from those who dropped out is omitted from analysis. Although the reasons for dropout do not appear to be related to the treatment, there is still risk of attrition bias. In addition, this large number of dropouts may have affected balance of patient characteristics by arm. The groups appeared balanced on measured confounders in table 1, but an effect of these dropouts on unmeasured confounders is unknown
Selective reporting (reporting bias) Low risk The study appears to be free of reporting bias
Other bias High risk Obsolete dialysis practice patterns (acetate buffered dialysate, parallel plate dialysers), with a patient sample that is not reflective of modern populations. Risk of poor external validity (indirectness)