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

Fernandez‐Perpen 2012.

Methods
  • Study design: prospective RCT, presumed open‐label (not disclosed)

  • Study duration: not reported

  • Follow‐up period: 24 months

Participants
  • Countries: Spain

  • Setting: multicentre (2 university hospitals)

  • Incident patients who are able and willing to perform CAPD with no expressed indication for APD

  • Number: treatment group (11); control group (20)

  • Mean age ± SD (years): treatment group (68.22 ± 8.8); control group (59 ± 15)

  • Sex (M/F): treatment group (8/3); control group (9/11)

  • Diabetic: treatment group (38%); control group (15%)

  • Exclusion criteria: none

Interventions Treatment group
  • BicaVera (1.5, 2.3%, 4.25% glucose)


Control group
  • Conventional PD fluid (Stay‐safe; 1.5%, 2.3% and 4.25%)

Outcomes
  • Peritonitis rate

  • Death

  • Technique survival

  • UF capacity

  • RRF

Notes
  • Study supported by grants from REDinREN, MLC and unrestricted grant from Fresenius Medical Care.

  • Note: significant difference in outcome re: UF capacity and RRF reported, but these differences were present from the baseline

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "patients were randomly assigned to either BicaVera or the standard PD fluid by the doctors"
Allocation concealment (selection bias) High risk Quote: "patients were randomly assigned to either BicaVera or the standard PD fluid by the doctors"
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 dropout rate (23 /31 (74.2%)). Imbalance in missing data between the two groups
Selective reporting (reporting bias) Low risk All relevant clinical outcomes reported
Other bias High risk Outcome parameters significantly different at baseline (e.g. urine volume, RRF)