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

Lin 2009a.

Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Follow‐up period: 4 weeks

Participants
  • Country: China

  • Setting: multicentre (7 sites)

  • Prevalent CAPD patients ≥ 18 years stable during at least 90 days; a minimum of 6 L of daily 2.5% Dianeal PD‐2 or PD‐4 dialysate with a night dwell above 8 hours; night dwell volume of 2 L for a minimum of 30 days before inclusion

  • Number: treatment group (98); control group (103)

  • Mean age ± SD (years): treatment group (56.8 ± 13.5); control group (55.4 ± 14.0)

  • Sex (M/F): treatment group (51/47); control group (45/58)

  • Exclusion criteria: documented anaphylaxis with icodextrin; concomitant chronic diseases such as hepatitis, malignancy, severe cardiac disease; ongoing infection or known infection within the last 30 days; planned or ongoing pregnancy; participation in another clinical or drug study concurrently

Interventions Treatment group
  • 7.5% icodextrin in night dwell


Control group
  • 2.5% glucose (Dianeal) in night dwell

Outcomes
  • Changes of peritoneal CrCl (mL/min)

  • Changes of UF volume

  • Metabolic parameters (fasting blood glucose, cholesterol, and triglycerides)

Notes
  • Additional information obtained from author

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was done using a computer program that generated numbers instead of treatment assignments"; block randomisation, using a 1:1 ratio
Allocation concealment (selection bias) Low risk Quote: "Envelopes that contained the number corresponding to the dialysate regiment were held by personnel not directly involved with the study, and could be opened only in an emergency"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Neither doctors nor patients knew the dialysate regimen"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Neither doctors nor patients knew the dialysate regimen"
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Low dropout rate, 18/201 (8.9%)
Selective reporting (reporting bias) Low risk All relevant clinical outcome parameters are reported
Other bias Unclear risk Insufficient information to permit judgement