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

Saxena 2006.

Methods
  • Study design: RCT

  • Study duration: March 2002 to February 2003

  • Duration of follow‐up: 18 months

Participants
  • Setting: single centre

  • Country: Saudi Arabia

  • Elderly participants who underwent reinsertion of a tunnelled central catheter through a new access site

  • Number (randomised/analysed/catheters): treatment group (60/59/61); control group (58/55/63)

  • Mean age ± SD (years): treatment group (78 ± 19); control group (75.5 ± 17)

  • Sex (M/F): Treatment group (36/22); control group (32/23)

  • Exclusion criteria: active sepsis, receiving prolonged (> 7 days) antibiotic therapy (oral/parenteral); allergies to cephalosporins; could not be randomised within 3 dialysis sessions of new tunnel catheter insertion; had the exchange over guidewires of a tunnelled catheter through the same exit site were also excluded

Interventions Treatment group
  • Cefotaxime: 10 mg/mL

  • Heparin: 5000 U/mL


Control group
  • Heparin: 5000 U/mL

Outcomes
  • CRI

  • Thrombosis

Notes
  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Use computer‐generated random number list
Allocation concealment (selection bias) Low risk Numbered, opaque, sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk The patient's and HD staff were blinded of the treatment assigned
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The microbiologist was blinded of the treatment assigned
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing outcome data
Selective reporting (reporting bias) Low risk Describes the outcome according to objective
Other bias Unclear risk Insufficient information to permit judgement