| Methods |
Study design: cross‐over RCT Study time frame: not stated Duration of follow‐up: 4 weeks |
| Participants |
Country: UK Setting: single centre -
Chronic HD patients hypotension‐prone (6 patients) or stable on HD
Number: 12 Mean age ± SD: 68 ± 11.2 years Sex (M/F): 10/2 Exclusion criteria: Hb < 10 g/dL, or if they had significant comorbidity that, in the opinion of the investigator, would make completion of the study unlikely |
| Interventions |
Treatment group
-
Acetate‐free HDF
Dialysis machine Formula 2000 (Bellco, Italy) “Diapes polyether sulphone double chamber dialyzers consisting of a combined 1.9 m2 dialyzer and 0.7 m2 ultrafilter (Bellco, Mirandola, Italy)
Control group
-
Low‐flux standard HD
Dialysis machine Formula 2000 (Bellco, Italy) Low‐flux filters LOPS 18/20 (Braun Medical Ltd., UK)
|
| Outcomes |
Changes in BP Cardiac function measurements (stroke volume, cardiac output), and total peripheral resistance in response to HD) Clinical tolerance/ Intradialytic hypotension Changes in cardiac troponin T |
| Notes |
Exclusions post randomisation but pre‐intervention: not stated Stop or end point/s: not stated Additional data requested from authors: method of randomisation; details regarding blinding, allocation concealment Funding: "The authors gratefully acknowledge Bellco, who provided the consumables and dialysis monitors for this study" |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Probably not done |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Probably not done |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Insufficient reporting |
| Selective reporting (reporting bias) |
High risk |
Study protocol unavailable and data for end of first phase of treatment not available |
| Other bias |
High risk |
Patients included were selected using two different inclusion criteria (prone to hypotension or stable patients) with no clear description of the initial number of analysed number. Carry over effect present because of the cross‐over design; data not extractable for meta‐analysis and interventions not matched |
