| Methods |
Study design: cross‐over RCT Study duration: not reported Follow‐up period: three study visits within 1‐3 week period |
| Participants |
Countries: UK, Sweden Setting: multicentre (8 sites) Prevalent adult patients on CAPD ≥ 18 years and experienced repeated infusion pain that based on medical judgement was not related to the catheter or excessive intraperitoneal volume of dialysis fluid Number: 18 Mean age: 63.5 years Sex (M/F): not reported Exclusion criteria: peritonitis within the previous 30 days |
| Interventions |
Patients evaluated during two dialysis exchanges with each test solution in random order. Thus, all patients underwent six separate study dwells, with a maximum of 2 test evaluations in 1 day, but it was required that these study exchanges were separated by a routine dwell (40 mM lactate solution) of at least 4 hours. All dwells for at least 3 hours, using 3.86% glucose solutions. Solutions used:
Lactate ‐ Dianeal PD4 Bicarbonate Bicarbonate/lactate
|
| Outcomes |
Pain scores Adverse symptoms |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Insufficient information to permit judgement |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double‐blind |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Double‐blind |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
1/18 (5.6%) lost to follow‐up |
| Selective reporting (reporting bias) |
Unclear risk |
Limited reporting of outcomes, but given short duration of study, not possible |
| Other bias |
High risk |
Large variation within the 8 participating centres in the frequency of inflow pain |
