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

Quereda 1988.

Methods
  • Study design: cross‐over RCT

  • Duration of study: not reported

  • Duration of follow‐up: 2 weeks

Participants
  • Country: Spain

  • Setting: single centre

  • Prevalent patients on HD (age criteria not reported)

  • Number: 8 patients allocated to control and then treatment, or treatment and then control, no attrition

  • Mean age ± SD: 58 ± 9 years

  • Sex (M/F): 2/6

  • Mean time on dialysis ± SD: 27 ± 22 months

  • None had diabetes mellitus

  • Exclusion criteria: not reported

Interventions HD regimen
  • Frequency not reported

  • Low‐flux cellulosic dialyser (PAN or CU)

  • Acetate buffer

  • QB and QD not reported

  • Kt/V and URR not reported


Treatment (performed in 8 phases)
  • CU dialyser + dialysate [Na+] 133 mM + temp 37

  • CU dialyser + dialysate [Na+] 139 mM + temp 37

  • PAN dialyser + dialysate [Na+] 133 mM + temp 37

  • PAN dialyser + dialysate [Na+] 139 mM + temp 37

  • CU dialyser + dialysate [Na+] 133 mM + temp 35

  • CU dialyser + dialysate [Na+] 139 mM + temp 35

  • PAN dialyser + dialysate [Na+] 133 mM + temp 35

  • PAN dialyser + dialysate [Na+] 139 mM + temp 35


Duration
  • 6 dialysis sessions for each patient on each phase (192 HD session with dialysate [Na+] 133 mM, 192 HD session with dialysate [Na+] 139 mM)

Outcomes
  • Outcomes were pooled by dialysate [Na+], since other interventions were identical across groups

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

    • Predialysis SBP

    • Intradialytic hypotension: "defined as a fall of systolic BP below 90 mm Hg."

    • IDWG

Notes
  • Funding source: not reported

  • This research was presented as 2 separate abstracts at EDTA and a local congress, and then published in Int Journal of Artificial Organs

  • SBP values were not reported in a format that could be analysed

  • Extra information was requested from the authors, but none was provided

  • Treatment groups were collapsed by dialysate [Na+], and given the identical sample sizes, the point estimates for each outcomes were calculated as the weighted mean from table 1, and the standard deviations as the square root of the weighted variances from table 1

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 Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk The study appears to be free of attrition bias
Selective reporting (reporting bias) Low risk The study appears to be free of reporting bias
Other bias High risk
  • Obsolete dialysis practice patterns (cellulosic dialysers, parallel plate dialysers), with a risk of poor external validity (indirectness)

  • No washout