NCT01689753

Effect of the TEGO Connector in Preventing Tunneled Cuffed Hemodialysis Catheters From Dysfunction and/or Bacteremia

Prevention of Tunneled Cuffed Hemodialysis Catheter-Related Dysfunction and Bacteremia by the TEGO® Connector: A Single-Center Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Other Complication of Vascular Dialysis Catheter

Interventions

Type	Name	Description
DEVICE	TEGO connector®
DRUG	Trisodium citrate

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-04-01
• Completion: 2011-03-01
• First posted: 2012-09-21
• Last updated: 2012-09-26

Locations

1 site across 1 country: Belgium