Completed

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

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What is being tested

TEGO connector®

+ Trisodium citrate

DeviceDrug
Who is being recruted

Infections

+ Catheter-Related Infections

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: March 2009
See protocol details

Summary

Principal SponsorErasme University Hospital
Last updated: September 26, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2009

Actual date on which the first participant was enrolled.

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.

Principal SponsorErasme University Hospital
Last updated: September 26, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

66 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsCatheter-Related Infections

Criteria

3 inclusion criteria required to participate
Adult HD patients, prevalent or incident,carrying a tunneled cuffed catheter

Patients having signed an informed consent

Tunneled cuffed catheter providing a mean blood flow superior to 250 ml/min

2 exclusion criteria prevent from participating
Episode of TCC-related bacteremia 1 week before randomization

Mature arterio-venous fistula

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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%.

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Erasme Hospital

Anderlecht, BelgiumOpen Erasme Hospital in Google Maps
CompletedOne Study Center