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

Choi 2008.

Methods

  • Study design: open parallel RCT

  • Study duration: not reported

  • Follow‐up period: 12 months
Participants

  • Country: Korea

  • Setting/ study design: single centre, university hospital

  • PrevaIent adult patients on CAPD; maintained on CAPD for at least 6 months prior to study enrolment using standard PD fluids, and considered to be adequately dialysed; patients used three or four 1.5 to 2.5 L exchanges/d

  • Number: treatment group (51); control group (53)

  • Mean age ± SD (years): treatment group (52.6 ± 12.4); control group (55.4 ± 11.9)

  • Sex (M/F): treatment group (20/31); control group (27/26)

  • Exclusion criteria: dialysis‐related complications (e.g. CAPD peritonitis, exit‐site infection, tunnel infection) within the previous 8 weeks; more than 2 episodes of peritonitis within the previous 6 months
Interventions Treatment group

  • Neutral pH, low GDP solution (Balance; Fresenius Medical Care)


Control group

  • Standard PD solution
Outcomes

  • Urine volume

  • Death (due to causes unrelated to PD)

  • 4‐hour dialysate:plasma creatinine

  • Change in D:P Cr over the study period

  • Peritoneal UF

  • Change in peritoneal UF

  • Kt/V urea (renal, peritoneal and total)

  • CrCl (renal, peritoneal and total)
Notes

  • Funding received from Yonsei University College of Medicine, the Korean Society of Nephrology and Fresenius Medical Care
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 Open‐label design thus 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 Large number of patients voluntarily changed to the low GDP PD solution (36/104 (35%)). Per protocol analysis
Selective reporting (reporting bias) Low risk All appropriate outcomes reported
Other bias Unclear risk Insufficient information to permit judgement