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

Lai 2012a.

Methods
  • Study design: parallel RCT

  • Study duration: commenced July 2003

  • Follow‐up period: average 3.6 years

Participants
  • Country: Hong Kong

  • Setting: multicentre (4 sites)

  • Incident adult patients on CAPD

  • Number: treatment group (58); control group (67)

  • Mean age ± SD (years): treatment group (56.4 ± 1.6); control group (59.5 ± 1.35)

  • Sex (M/F): treatment group (36/22); control group (33/34)

  • Exclusion criteria: malignancy; systemic lupus erythematosus; chronic valvular or congenital heart disease

Interventions Treatment group
  • low‐GDP PDFs, Gambrosol Trio, Physioneal 40 and Balance


Control group
  • Conventional PD Solutions ‐ lactate‐buffered glucose based Dianeal PD‐2 or ANDY‐Disc

Outcomes Composite co‐primary outcomes
  • biochemical profile of cytokines, growth factors, adipokines, and cardiac biomarkers determined after stable PD treatment for an average duration of 2.3 years

  • dialysis adequacy determined by GFR and daily urine output at initiation and at the time of census after stable PD for an average duration of 3.6 years


Also determined
  • UF

  • Urine volume

  • Dialysis Adequacy (Kt/V, CrCl)

  • Residual GFR

  • 4‐hour dialysate:plasma creatinine

Notes
  • Study supported in part by a Renal Discoveries‐International Society of Nephrology grant and a Baxter extramural grant

  • Randomisation and recruitment into this study unusual. Patients were informed only at 2.3 years after starting their 'study' of their participation

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Random assignments were made by the patient's training nursing officer at the individual renal centre
Allocation concealment (selection bias) High risk Random assignments were made by the patient's training nursing officer at the individual renal centre
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Open‐label, however unlikely to have affected the objective outcomes measured
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Per protocol analysis
Selective reporting (reporting bias) High risk Peritonitis not reported
Other bias High risk Although baseline characteristics were reported to be similar. The paper did not disclose the duration of PD that these patients received, so one cannot exclude that they may represent different vintage.
Also, for biochemical analyses, there is no baseline value available, thus it is difficult to be certain whether differences are present truly or due to type I error
Multiple types of PD solutions used in intervention and control groups.