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

Sofroniadou 2012.

Methods
  • Study design: parallel RCT

  • Study duration: December 2004 and June 2008

  • Duration of follow‐up: not reported

Participants
  • Setting: single centre

  • Country: Greece

  • Participants required a temporary non‐tunnelled catheter for commencement or maintenance of HD on the basis of ESKD

  • Number (participants/catheters): 135/156; treatment group 1 (not reported/49); treatment group 2 (not reported/52); control group (not reported/51)

  • Mean age, range (years): treatment group 1 (72, 62 to 80); treatment group 2 (67.5, 47 to 75); control group (72, 65 to 77)

  • Sex (males): treatment group 1 (30); treatment group 2 (28); control group (33)

  • Exclusion criteria: active systemic or localized infection under antibiotic treatment; sepsis; allergy to heparin, vancomycin or linezolid; heparin‐induced thrombocytopenia and thrombosis mediated by antiheparin antibodies; pregnancy; catheter was used for any other reason than for HD; AKI requiring HD use of immunosuppressive drugs; diagnosis of a current malignancy

Interventions Treatment group 1
  • Vancomycin: 5 mg/mL

  • Unfractionated heparin: 2000 U/mL


Treatment group 2
  • Linezolid: 2 mg/mL

  • Unfractionated heparin: 2000 U/mL


Control group
  • Heparin: 2000 U/mL

Outcomes
  • CRI

  • CRI‐free survival

  • Exit site infections

  • Bacterial colonisation

  • Thrombosis

Notes
  • Funding source: none

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Table of random numbers
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 No missing outcome data
Selective reporting (reporting bias) Low risk Describes the outcome according to protocol
Other bias Unclear risk Insufficient information to permit judgement