Methods |
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Participants |
Countries: Germany, Sweden, UK
Setting: multicentre (number not reported)
Prevalent adult patients > 18 years on APD or CAPD; uncontrolled hypertension (BP > 140/90 mmHg), treated hypertension, or a dialysis prescription with a daily average glucose concentration of ≥ 2.27%; high or high‐average peritoneal solute transport (corrected 4h D/P creatinine ratio ≥ 0.65); urine output ≤ 750 mL/d; patient tolerance of a dialysis regimen with a long dwell of ≥ 6 hours with 2.27% glucose with fill volume of 1.5 to 2.5 L; able to give written informed consent; on PD for at least 90 days
Number: treatment group (28); control group (22)
Mean age ± SD (years): treatment group (56 ± 15); control group (54 ± 15)
Sex (males): treatment group (54%); control group (45%)
Exclusion criteria: received icodextrin or other non‐glucose solutions in the 30 days before randomisation; treated for peritonitis in the 30 days before randomisation; considered noncompliant; considered to have hypertension despite being clinically volume depleted; use of a 1.36% glucose solution for each exchange; allergy to starch; glycogen storage disease; life expectancy < 12 months; serious illness or injury in the 30 days before randomisation that would invalidate study entry; participation in another interventional study; pregnant or lactating; significant psychiatric disorder that would interfere with their ability to provide informed consent and/ or comply with the study procedures
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Interventions |
Treatment group
Control group
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Outcomes |
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Notes |
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Quote from Methods section of paper: "Randomised 1:1 with stratification for centre/country, dialysis modality (CAPD or APD), and presence of cardiovascular disease or LVH" |
Allocation concealment (selection bias) |
Low risk |
Quote from Methods section of paper: "The treatment codes were supplied to study sites in sealed envelopes, which were checked at the end of the study" |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote from Methods section of paper: "Identity of the long‐dwell solution blinded to patients, investigators and clinical monitors; specially created packaging was used to conceal which solution was which solution was which" |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Insufficient information to permit judgement |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Drop‐out rate 20% (10/50). Quote from Results section of paper: "Additional withdrawals from the 2.27% glucose group were for UF failure and patient preference" |
Selective reporting (reporting bias) |
Low risk |
All relevant outcomes reported |
Other bias |
Unclear risk |
Insufficient information to permit judgement |