| Methods |
Study design: parallel RCT Study duration: May 1999 to June 2001 Duration of follow‐up: 6 months |
| Participants |
Setting: multicentre (25 centres) Country: USA Adult with ESKD > 18 years receiving HD 3 times/wk through a cuffed and tunnelled internal jugular venous catheter with a mean baseline flow rate of 300 mL/min, if they had no clinical or laboratory evidence of active infection within the preceding 30 days and a negative pre‐enrolment blood culture Number (patients randomised/analysed/catheters): treatment group (209/201/201); control group (207/206/206) Mean age ± SD (years): treatment group (62.2 ± 15.4); control group (61.7 ± 15.2) Sex (M): treatment group (48.8%); control group (51.5%) Exclusion criteria: femoral and subclavian catheters; catheters with antithrombotic or antimicrobial coatings; pregnancy; thrombocytopenia or other chronic coagulopathy; history of heparin‐induced thrombocytopenia; antibiotic therapy within 14 days of enrolment (30 days for vancomycin); hypersensitivity to heparin, sodium citrate, methylene blue, methylparaben, or propylparaben; current infection or who were under antibiotic therapy |
| Interventions |
Treatment group
Control group
|
| Outcomes |
CRI Patency failure Adverse effects |
| Notes |
Funding source: " Supported, in part, by National Institute of Diabetes and Digestive and Kidney Diseases 5 R44 DK071369‐03; the Indiana 21st Century Research and Technology Fund; the Oscar Rennebohm Foundation of Madison, WI; the National Institutes of Health; and Ash Access Technology" "Dr. Ash is the founder and reports ownership of Ash Access Technology. Dr. Ash has stock ownership and options in Ash Access Technology and received patents from Ash Access Technology related to this product. Mr. Winger is employed by Ash Access Technology and reports ownership and stock options. Dr. Lavin is employed by Averion International. Averion International was compensated by Ash Access Technology for clinical monitoring, statistical analysis, and clinical event committee support for this study." |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Eligible consenting participants were randomised 1:1 to one of the two treatment groups from computer‐generated randomizations lists |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Open‐label study |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
An independent committee assessed the outcome and was blinded to patient treatment assignment |
| 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 |
Low risk |
Study appears free of other biases |
