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

Bajo 2011.

Methods
  • Study design: parallel RCT

  • Study duration: 4 years

  • Follow‐up period: 24 months

Participants
  • Country: Spain

  • Setting: multicentre (2 sites), university hospital

  • Incident adult CAPD patients

  • Number: treatment group (13); control group (20)

  • Mean age ± SD (years): treatment group (62 ± 11); control group (59 ± 15)

  • Sex (M/F): treatment group (10/3); control group (9/11)

  • Exclusion criteria: none

Interventions Treatment group
  • Balance (Fresenius Medical Care)


Control group
  • Standard PD fluid (Stay Safe)

Outcomes
  • Peritonitis rate

  • Peritoneal UF (4 hours, 4.25% glucose solution)

  • RRF

  • Patient survival

Notes
  • Supported by grants from RETICS from Instituto de Salud Carlos III and unrestricted grant from Fresenius Medical Care

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "patients were alternately assigned to either 'balance' or standard PD fluid depending on the time point of inclusion"
Allocation concealment (selection bias) High risk Quote: "patients were alternately assigned to either 'balance' or standard PD fluid depending on the time point of inclusion"
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 High risk High drop‐out rate: 21/33 (63.6%)
Selective reporting (reporting bias) Low risk All relevant outcomes reported
Other bias High risk Outcome parameters significantly different at baseline (e.g. urine volume, RRF)