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
Treatment group 2
Control group
|
Outcomes |
CRI
CRI‐free survival
Exit site infections
Bacterial colonisation
Thrombosis
|
Notes |
|
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 |