Skip to main content
. 2018 Apr 3;2018(4):CD010597. doi: 10.1002/14651858.CD010597.pub2

Betjes 2004.

Methods
  • Study design: parallel RCT

  • Study duration: May 2002 to June 2003

  • Duration of follow‐up: 90 days

Participants
  • Setting: single centre

  • Country: Netherlands

  • Patients who needed a HD catheter for starting or continuing HD treatment

  • Number: 58 randomised, 76 catheters; treatment group (37 catheters); control group (39 catheters)

  • Mean age ± SD (years): treatment group (58.3 ± 16.3); control group (50.3 ± 20.4)

  • Sex (M): treatment group (56.8%); control group (61.5%)

  • Exclusion criteria: HD catheter was used on the ICU or for reasons other than HD; using antibiotics

Interventions Treatment group
  • Sodium citrate: 4%

  • Taurolidine: 1.35%


Control group
  • Heparin: 5000 U/mL

Outcomes
  • CRI

  • Clinical exit‐site infection

  • Bacterial colonisation

  • CRS or bacterial colonisation‐free survival

Notes
  • Nasal mupirocin was administered to participants

  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "...computer‐generated table of random numbers. The randomization procedure
 was done independent of type of catheter or place of insertion"
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
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 outcome data reported
Selective reporting (reporting bias) Low risk Study protocol not available but published results include all expected outcomes
Other bias Unclear risk Funding sources not reported