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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Other Complication of Vascular Dialysis Catheter

Intervention / Treatment
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* Device: TEGO connector®
* Drug: Trisodium citrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEGO® connector<br>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%. | Device: TEGO connector®<br> <br> |
| Active Comparator: Trisodium citrate<br>After each dialysis, the dead space of the catheter is filled with trisodium citrate 46.7% (Citralock®). | Drug: Trisodium citrate<br> <br> * Other names: Citralock®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal dialyse, Catheter, indwelling, Catheter-related infection