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

TRIO 2016.

Methods
  • Study design: RCT

  • Study duration: August 2005 to July 2010

  • Follow‐up period: 24 months

Participants
  • Countries: Canada and Hong Kong

  • Setting: multicentre

  • Incident adults CAPD or APD patients

  • Number: treatment group (51); control group (50)

  • Mean age ± SD (years): treatment group ( 59.9 ± 11); control group (59.0 ± 11)

  • Sec (M/F): treatment group (29/22); control group (31/19)

  • Exclusion criteria: unlikely to continue PD for at least 6 months

Interventions Treatment group
  • Neutral pH, low GDP PD solution (Gambrosol Trio solution)


Control group
  • Conventional PD solution (Dianeal solution)

Outcomes
  • RRF

  • Urine output

  • 4‐hour dialysate:plasma creatinine

  • Peritoneal small solute clearance

  • Peritoneal UF

  • peritonitis rate

Notes
  • "The Trio Trial was partially funded by an unrestricted grant from Gambro Lundia AB, Lund, Sweden. TS, GW, MT, DO, and PT conceived, designed, and supervised the Trio Trial. TS, SM, AS, and MA conducted the statistical analysis"

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Standard computerized algorithm
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Open‐label, unlikely to have major impact on outcomes of study
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Unlikely to effect the outcomes of study
Incomplete outcome data (attrition bias) 
 All outcomes High risk 33% dropout rate
Selective reporting (reporting bias) Low risk All outcomes of study were reported
Other bias Unclear risk Insufficient information to permit judgement