Other Complication of Vascular Dialysis Catheter Clinical Trial
Official title:
Prevention of Tunneled Cuffed Hemodialysis Catheter-Related Dysfunction and Bacteremia by the TEGO® Connector: A Single-Center Randomized Controlled Trial
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%.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention