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

Feriani 1998.

Methods
  • Study design: parallel, open label RCT

  • Study duration: not reported

  • Follow‐up period: 24 weeks

Participants
  • Countries: Germany

  • Setting: multicentre (14 sites)

  • Adult patients on CAPD (prevalent) who were free of peritonitis for at least 4 weeks preceding the study commencement.

  • Phase II study (24 weeks)

    • Number: treatment group (37); control group (36)

    • Median age, range (years): treatment group (54.5, 18.6‐78); control group (55, 21.27‐79.4)

    • Sex (M/F): treatment group (17/20); control group (20/16)

  • Exclusion criteria: not reported

Interventions Treatment group
  • 34 mmol/L bicarbonate‐buffered solution


Control group
  • 35 mmol/L lactate‐buffered PD solution

Outcomes
  • RRF

  • UF

  • Subjective assessment ‐ symptoms

  • Adverse events

Notes
  • Grant from Fresenius

  • Phase I study data only available from conference abstract

  • 36 patients left at the end of phase I of study ‐ no explanation provided

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised centrally and separately for each study centre and block randomisation in steps of four used
Allocation concealment (selection bias) Low risk No specific information provided. However central randomisation with probable low risk of selection bias
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open label, may have affected symptom assessment
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 participants missing between two phases of study that are not accounted for in the paper: 18/123 (14.6%) for 12 weeks; 4/73 (5.5%) for 24 week study
Selective reporting (reporting bias) Low risk All relevant clinical outcomes reported
Other bias Unclear risk Insufficient information to permit judgement