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. 2018 Oct 26;2018(10):CD007554. doi: 10.1002/14651858.CD007554.pub3

Davies 2003.

Methods
  • Study design: parallel RCT

  • Study duration:

  • Follow‐up period: 6 months

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

Interventions Treatment group
  • 7.5% icodextrin for the long dwell


Control group
  • 2.27% glucose (Dianeal) for the long dwell

Outcomes
  • Decline in RRF (change in urine output)

  • Change in peritoneal UF volume

Notes
  • Funded by Baxter Healthcare

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