Skip to main content
. 2018 Oct 26;2018(10):CD007554. doi: 10.1002/14651858.CD007554.pub3

Rippe 2001.

Methods

  • Study design: open label, parallel RCT

  • Study duration: not reported

  • Follow‐up period: 24 months (initially planned for 12 month study, extended to 24 months without additional patient recruitment)
Participants

  • Country: Denmark, Sweden

  • Setting: multicentre (5 centres)

  • Adult incident and prevalent CAPD patients, > 18 years, able to use 2L bags with a calcium concentration of 1.35 mmol/L

  • Number: treatment group (40); control group (40)

  • Mean age, range (years): treatment group (58, 28 to 80); control group (57, 26 to 82)

  • Sex (M/F): treatment group (25/15); control group (30/10)

  • Exclusion criteria: seropositive for hepatitis B or HIV; malignancy; pregnant
Interventions Treatment group

  • neutral pH, low GDP PD solution


Control group

  • Gambrosol 40 CAPD solution
Outcomes

  • Personal dialysis capacity (PDP) used as a tool to:

    • Assess peritoneal transport characteristics

    • Evaluate RRF

  • UF following overnight dwell using 2.5%

  • Dialysate markers ‐ e.g. CA125, hyaluronan, PICP, PIINP

  • Infusion pain
Notes

  • Supported by Gambro

  • Pain assessment not blinded
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Central randomisation office (stratified randomisation with respect to patient age (< 55, > 55 years), diabetes (using insulin or not), and time on PD (< 9 months, > 9 months))
Allocation concealment (selection bias) Low risk Not reported but presume low risk given central randomisation
Blinding of participants and personnel (performance bias) 
 All outcomes High risk "Open‐label". During pain assessment phase, no blinding took place which may have affected patient response
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk Although all dropouts accounted for, extremely high proportion (67/80, 83.75%) did not complete the study duration
Selective reporting (reporting bias) High risk RRF not reported
Other bias Unclear risk Insufficient information to permit judgement