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. 2018 Apr 3;2018(4):CD010597. doi: 10.1002/14651858.CD010597.pub2

Vercaigne 2016a.

Methods
  • Study design: parallel RCT

  • Study duration: August 2011 to May 2013

  • Duration of follow‐up: not reported

Participants
  • Setting: multicentre (2)

  • Country: Canada

  • Participants: treatment group (20); control group (19)

  • Mean age, range (years): treatment group (63, 22.4 to 83.2); control group (62.3, 36.1 to 88.0)

  • Sex (M/F): treatment group (12/8); control group (9/10)

  • Exclusion criteria: critically ill in ICU setting; AKI and unlikely to require prolonged vascular access; maturing or planned AV fistula/graft creation within 2 months; planned antibiotics treatment courses not lasting longer than 4 weeks from the date of the new catheter insertion

Interventions Treatment group
  • Ethanol: 30%

  • Sodium citrate: 4%


Control group
  • Heparin: 1000 U/mL

Outcomes
  • Serious adverse events

  • CRI

  • Catheter dysfunction

Notes
  • Pilot study

  • Funding source: "This study was supported in part by MedXL Inc., Pointe‐Claire, QC, Canada."

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "...randomised centrally in permuted blocks of four using computer software (Microsoft Excel 2010 Microsoft Corporation). Randomization was stratified based on whether the catheter was inserted into a new location or changed over a guide wire."
Allocation concealment (selection bias) Low risk Opaque sealed envelopes were used
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Ethanol has a distinctive smell
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patient data reported
Selective reporting (reporting bias) Low risk Describes the outcome according to protocol
Other bias Unclear risk Study parted funded by MedXL Inc (medical devices and prefilled syringes)