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

Free University of Brussels (ULB)

Status: Completed

Conditions: Other Complication of Vascular Dialysis Catheter

Treatments: Device: TEGO connector®; Drug: Trisodium citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01689753

P2009/021

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

TEGO® connector

Experimental group

Description:

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%.

Treatment:

Device: TEGO connector®

Trisodium citrate

Active Comparator group

Description:

After each dialysis, the dead space of the catheter is filled with trisodium citrate 46.7% (Citralock®).

Treatment:

Drug: Trisodium citrate