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

McIntyre 2004.

Methods
  • Study design: parallel RCT

  • Study duration: March 2002 to April 2003

  • Duration of follow‐up: not reported

Participants
  • Setting: single centre

  • Country: UK

  • Participants to have had no evidence of CRI, having been antibiotic free for at least 28 days before catheter insertion

  • Number (participants/catheters): treatment group (25/25); control group (25/25)

  • Mean age ± SD (years): treatment group (63.6 ± 2.8); control group (57.8 ± 3.2)

  • Sex (M/F): treatment group (18/7); control group (14/11)

  • Exclusion criteria: catheter was an exchange reinsertion; insertion at a separate site (with previous catheter still in situ); recent infection; those on immunosuppressant medications

Interventions Treatment group
  • Gentamicin: 5 mg/mL

  • Heparin: 5000 IU/mL.


Control group
  • Heparin: 5000 U/mL

Outcomes
  • CRI

  • Catheter malfunction

Notes
  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The study was block randomised; method of randomisation not reported
Allocation concealment (selection bias) Unclear risk Randomisation was performed by sealed envelope, but not opaque
Blinding of participants and personnel (performance bias) 
 All outcomes High risk By the characteristics of the solution used, blinding of intervention was not possible
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 analyses were performed on an intention‐to‐treat basis
Selective reporting (reporting bias) Low risk Describes the outcome according to protocol
Other bias Unclear risk Insufficient information to permit judgement