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

Pajek 2008.

Methods

  • Study design: open label, cross‐over RCT

  • Study duration: not reported

  • Follow‐up period: 6 months
Participants

  • Country: Slovenia

  • Setting: single‐centre, University hospital

  • Prevalent CAPD patients (adult), treated with Dianeal solution for at least 3 months and > 18 years

  • Number: 21

  • Mean age ± SD: 54.3 ± 12.4 years

  • Sex (M/F): 13/8

  • Exclusion criteria: peritonitis episode in the last 3 months; a history of or current systemic inflammatory disease or immunomodulatory therapy; HIV, HBV or HCV positivity or other chronic infectious disease; malignant disease; acute exacerbation of heart failure in the last 3 months prior to inclusion in the study
Interventions

  • After 1‐month run‐in phase with the Dianeal solution (D solution), patients were randomised (1:1) to either 3 months of treatment with the D solution (group D‐P) or to 3 months of treatment with Physioneal 40 (P solution; group P‐D)

  • After 3 months, patients switched therapies to receive a further 3 months of treatment
Outcomes Primary endpoint

  • Daily UF


Secondary endpoints

  • Overnight UF of a timed 10‐hour dwell

  • 4‐hour UF with 2.27% solution on PET

  • Low‐molecular‐weight solute peritoneal transport rates expressed as a D/P for creatinine ratio and D/D1 for glucose ratio

  • Peritoneal urea and CrCl

  • Residual GFR
Notes

  • Study partly supported by a grant from the Slovenian Research Agency and partly by a grant from Baxter Healthcare, Ljubljana, Slovenia. One of the authors is employed by Baxter Healthcare
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement other than, quote: "patients were randomized (1:1)"
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "open‐label, randomized". However, unlikely to have influenced the measured objective outcomes
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Dropout rate ‐ 5/26 (19.2%). Per protocol analysis
Selective reporting (reporting bias) Low risk All relevant outcomes reported
Other bias Unclear risk Insufficient information to permit judgement