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

Saxena 2012.

Methods
  • Study design: RCT

  • Study duration: April 2005 to March 2006

  • Duration of follow‐up: not reported

Participants
  • Setting: multicentre (2)

  • Country: Saudi Arabia

  • Participants > 18 years carrying S. aureus that would require the installation of a tunnelled central catheter for HD start or maintenance

  • Number (participants/catheters): treatment group (39/41); control group (43/47)

  • Mean age ± SD (years): treatment group (53.7 ± 17.2); control group (51.9 ± 19.1)

  • Sex (M/F): treatment group (23/16); control group (26/17)

  • Exclusion criteria: active sepsis receiving prolonged antibiotic therapy; hypersensitivity to heparin or cephalosporins; catheter exchanged over a guidewire; existing exit‐site or tunnel infection; pregnant women

Interventions Treatment group
  • Cefotaxime: 10 mg/mL

  • Heparin: 5000 U/mL


Control group
  • Heparin: 5000 U/mL

Outcomes
  • CRI

  • Death related to CRI

  • Exit site infection

Notes
  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random number
Allocation concealment (selection bias) Low risk Sealed, opaque envelopes, numbered in sequence
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk The pharmacy dispensed equal number of identical syringes
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Microbiologist was blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patient outcome data reported
Selective reporting (reporting bias) Low risk Describes the outcome according to protocol
Other bias Unclear risk Insufficient information to permit judgement