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

Cnossen 2011.

Methods
  • Study design: open, parallel RCT

  • Study duration: not reported

  • Follow‐up period: 3 months

Participants
  • Country: Germany, Netherlands

  • Setting: multicentre (2)

  • PrevaIent adult patients on CAPD

  • Number: treatment group (12); control group (11)

  • Mean age ± SD (years): treatment group (70.0 ± 13.1); control group (55.3 ± 15.6)

  • Sex (M/F): treatment group (9/3); control group (10/1)

  • Exclusion criteria: intercurrent infection; use of 1.1% amino acids (Nutrineal, Baxter Healthcare); treatment with APD

Interventions Treatment group
  • Neutral pH, low GDP solution (Physioneal; Baxter Healthcare)


Control group
  • Standard PD fluid (Dianeal, Baxter Healthcare)

Outcomes
  • Advanced glycation end product concentrations

  • RRF

Notes
  • Significant disparity in baseline age between the two groups noted. Author contacted, awaiting response

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 Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Low drop‐out rate (3/26 (11.5%))
Selective reporting (reporting bias) High risk Limited reporting of clinical outcomes
Other bias High risk A large difference in baseline age between the treatment and control groups raise concern for inadequate randomisation