| Methods |
Study design: cross‐over RCT Study time frame: not stated Duration of follow‐up: 15 months |
| Participants |
Country: Spain Setting: multi‐centre (6 centres) -
Chronic HD patients on dialysis for at least 3 months; age > 18 years; thrice‐weekly HD; stable regimen of anticoagulation and EPO; HCT > 28%; blood flow rate > 250 mL/min
Number (enrolled/randomised/analysed): 35/30/21 Mean age ± SD: 62 ± 14 years Sex (M/F): 20/15 Exclusion criteria: coagulation problems; survival rate < 18 months; diuresis > 400 mL/24h; CrCl > 2 mL/min |
| Interventions |
Treatment group
Predilution HDF acetate‐free dialysate for 6 months, 3 to 4 hours, 3 times/week (611 free‐acetate, Bellco, Mirandola, Italy)
Control group
Predilution HDF with conventional bicarbonate dialysate for 6 months, 3 to 4 hours 3 times/week (Formula dialysis machine, Bellco, Mirandola, Italy)
|
| Outcomes |
Number of hypotensive episodes (fall in SBP < 95 mm Hg, associated with symptoms requiring the intervention of healthcare professionals) HD tolerance (number of headaches episodes, pruritus, vomiting or cramps per month) Variation of biochemical parameters B2 microglobulin |
| Notes |
Exclusions post randomisation but pre‐intervention: 5 patients Stop or end point/s: not stated Additional data requested from authors: method of randomisation; details regarding blinding, supplementary data about hypotensive events, other non‐reported outcomes Funding: not stated |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information, the method of concealment is 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 |
High risk |
"no difference for dialysis tolerance between the groups"; no intention‐to‐treat analysis; lost to follow‐up (9; no clear description of drop‐outs, reasons or belonging) |
| Selective reporting (reporting bias) |
High risk |
Not all of the study's pre‐specified primary outcomes have been reported; data at the end of first phase of treatment not available |
| Other bias |
High risk |
Important difference between selected and analysed patients (e.g. dialysis vintage 249 months in the selected initial group versus 164 months in the analysed group); carry over effect present because of the cross‐over design |
