| Methods |
Study design: cross‐over RCT Study time frame: not stated Duration of follow‐up: 1 week |
| Participants |
Country: Italy Setting: single centre Patients on regular bicarbonate HD for at least 12 months Number: 5 Mean age ± SD: 57.6 ± 9.6 years Sex (M/F): 3/2 Exclusion criteria: history or clinical evidence of unstable angina, MI, stroke or TIA; uncontrolled hypertension (diastolic BP > 100 mm Hg); severe systemic disease; on drugs known to affect haemostasis; fever or signs of acute infection, inactive immunological processes; hypersensitivity to dialysis membrane material |
| Interventions |
Treatment group
Control group
Co‐interventions: not stated |
| Outcomes |
Pre‐ and post‐dialysis systolic BP Difference between in pre‐ and post‐dialysis systolic BP Pre‐ and post‐dialysis diastolic BP Difference between pre‐ and post‐dialysis BP Pre‐ and post‐dialysis body weight Difference between pre‐ and post‐dialysis body weight Kt/V |
| 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 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 |
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 |
Unclear risk |
Missing outcome data balanced across groups; 0/5 lost to follow‐up |
| Selective reporting (reporting bias) |
High risk |
Data for end of first phase of treatment not available; no protocol of the study available |
| Other bias |
High risk |
Carry over effect present because of the cross‐over design; data not extractable for meta‐analysis and interventions not matched |
