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

Fan 2008.

Methods

  • Study design: parallel RCT

  • Study duration: 1 January 2004 to 31 December 2005

  • Follow‐up: 12 months
Participants

  • Country: UK

  • Setting: single centre

  • Incident adult patients on APD or CAPD

  • Number: treatment group (57); control group (61)

  • Mean age ± SD (years): treatment group (51.6 ± 2); control group (54.5 ± 1.7)

  • Sex (M/F): treatment group (38/19); control group (39/22)

  • Exclusion criteria: not reported
Interventions Treatment group

  • Biocompatible solution (Physioneal or Balance depending on the connectology that was felt to be best suited to the individual)


Control group

  • Standard PD solution (Dianeal or Stay Safe depending on the connectology that was felt to be best suited to the individual)
Outcomes

  • RRF (assessed by 24‐h urine collection)

  • Peritonitis rate

  • PD technique survival

  • Changes in peritoneal membrane function using PET

  • Biomarker of inflammation, CRP
Notes

  • Differences in connectology may have influenced the peritonitis risk.

  • Baxter group also allowed to use Nutrineal/Icodextrin
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 Low risk No blinding of investigators or participants. However, unlikely to have impacted on objective clinical outcomes (e.g. urine volume)
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk Dropout rate of 21.2% (25/118). Not all accounted for with many under "did not complete". Reason unclear
Selective reporting (reporting bias) Low risk All relevant outcomes reported
Other bias High risk Issue of connectology and allowance of Nutrineal/icodextrin usage in patients who used Baxter System.
Multiple types of PD solutions used in both intervention and control groups