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. 2019 May 31;2019(5):CD004680. doi: 10.1002/14651858.CD004680.pub3

Timely PD 2010.

Methods
  • Study design: parallel RCT

  • Study time frame/recruitment period: 1 March 2008 to 31 May 2013

  • Follow‐up period: day 180 post catheter insertion

Participants
  • Country: Australia

  • Setting: multicentre (2 sites)

  • ESKD patients over 18 years of age, who will be receiving CAPD or APD within 4 weeks of insertion of a PD catheter

  • Number: treatment group 1 (39); treatment group (42); control group (41)

  • Mean age ± SD (years): treatment group 1 (60.92 ± 15.2); treatment group 2 (57.55 ± 17.9); control group (54.41 ± 15.5)

  • Sex (M/F): treatment group 1 (22/17); treatment group 2 (20/22); control group (26/15)

  • Diabetes: treatment group 1 (15/39); treatment group 2 (14/42); control group (14/41)

  • Exclusion criteria: a history of psychological illness or condition which resulted in inability to understand or comply with the requirements of the study or if there is an acute infectious episode in the last month before enrolment

Interventions Treatment group 1
  • One‐week break‐in period


Treatment group 2
  • Two‐week break‐in period


Control group
  • Four‐week break‐in period

Outcomes
  • Composite of exit‐site infection or tunnel tract or peritonitis

  • Peritoneal fluid leak

  • Technique failure

Notes
  • Funding source: "This study is partly funded by research grants from the Baxter Renal Division Clinical Evidence Council"

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation sequence was generated using STATA software (permuted block)
Allocation concealment (selection bias) Low risk Sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Not blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropout
Selective reporting (reporting bias) Low risk Published protocol before study
Other bias High risk Protocol violation present