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

Not Applicable

Completed

• Conditions: Other Complication of Vascular Dialysis Catheter
• Interventions: Device: TEGO connector®; Drug: Trisodium citrate

• Registration Number: NCT01689753
• Lead Sponsor: Erasme University Hospital

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.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2010-04
• Study Completion: 2011-03
• Study First Submitted: 2012-07-23
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-21
• Last Update Submitted: 2012-09-25
• Last Update Posted: 2012-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEGO® connector	TEGO connector®	The TEGO® connector is used during 3 consecutive hemodialyse. After each dialysis session, the dead space of the catheter is flushed with NaCl 0.9%.
Trisodium citrate	Trisodium citrate	After each dialysis, the dead space of the catheter is filled with trisodium citrate 46.7% (Citralock®).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Erasme Hospital; 🇧🇪 Anderlecht, Brussel, Belgium