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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
66
Erasme Hospital
Anderlecht, Brussels Capital, Belgium
Incidence rate of tunneled cuffed catheter-related dysfunction or bacteremia (composite endpoint)
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.
Time frame: 16 months
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