Other Complication of Vascular Dialysis Catheter
Conditions
Keywords
Renal dialyse, Catheter, indwelling, Catheter-related infection
Brief summary
The aim of the trial was to assess whether use of the TEGO connector was able to reduce the incidence of a composite endpoint of TCC-related dysfunction (TCC-D)or TCC-related bacteremia (TCC-B) in chronic hemodialysis (HD) patients carrying the TEGO® connector vs controls receiving trisodium citrate 46.7%.
Detailed description
The TEGO® connector (ICU Medical, www.icumed.com) is a closed positive pressure system, flushed with 0.9% sodium chloride and attached on the hubs of the TCC. As recommended by the producer, the TEGO® remains during 3 consecutive HD sessions and is changed every week. By constituting a mechanical barrier, it could be an interesting alternative to reduce the intraluminal contamination and the risk of TCC-B. The TEGO® connector is supposed to provide an automatic positive displacement of fluid at the end of each TCC flush. This positive pressure could prevent the reflux of blood into the TCC lumen, possibly resulting in TCC-D. As the impact of the TEGO® connector on TCC-D and TCC-B has never been studied, we conducted a randomized controlled study in our center by comparing the anti-thrombotic and anti-infectious efficacy of the TEGO® connector to trisodium citrate 46.7% (Citralock®, Dirinco, www.citra-lock.com) . The global cost of both procedures was also evaluated.
Interventions
DEVICETEGO connector®
Sponsors
Erasme University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult HD patients, prevalent or incident,carrying a tunneled cuffed catheter * Tunneled cuffed catheter providing a mean blood flow superior to 250 ml/min * Patients having signed an informed consent
Exclusion criteria
* Mature arterio-venous fistula * Episode of TCC-related bacteremia 1 week before randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of tunneled cuffed catheter-related dysfunction or bacteremia (composite endpoint) | 16 months | Tunneled cuffed catheter dysfunction was defined by the requirement of urokinase and/or a mean blood flow \< 250 ml/min during two consecutive hemodialysis sessions. Tunneled cuffed catheter bacteremia was defined by ≥ 2 positive qualitative and/or quantitative positive blood cultures. |
Countries
Belgium
Outcome results
None listed