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
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
|
Outcomes |
Outcomes were pooled by dialysate [Na+], since other interventions were identical across groups
-
Outcomes were assessed over the entire period of treatment/observation:
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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 |
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