Clinical trial NCT01689753: Effect of the TEGO Connector in Preventing Tunneled Cuffed Hemodialysis Catheters From Dysfunction and/or Bacteremia
Official title: Prevention of Tunneled Cuffed Hemodialysis Catheter-Related Dysfunction and Bacteremia by the TEGO® Connector: A Single-Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Complication of Vascular Dialysis Catheter
Keywords: Renal dialyse
Catheter, indwelling
Catheter-related infection
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence rate of tunneled cuffed catheter-related dysfunction or bacteremia (composite endpoint)
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: Erasme Hospital
state: Brussel
Study officials:
affiliation: Nephrology Dept, Erasme Hospital. Université Libre de Bruxelles, Brussel
name: Joëlle Nortier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bosma JW, Siegert CE, Peerbooms PG, Weijmer MC. Reduction of biofilm formation with trisodium citrate in haemodialysis catheters: a randomized controlled trial. Nephrol Dial Transplant. 2010 Apr;25(4):1213-7. doi: 10.1093/ndt/gfp651. Epub 2009 Nov 30.
citation: Shanks RM, Sargent JL, Martinez RM, Graber ML, O'Toole GA. Catheter lock solutions influence staphylococcal biofilm formation on abiotic surfaces. Nephrol Dial Transplant. 2006 Aug;21(8):2247-55. doi: 10.1093/ndt/gfl170. Epub 2006 Apr 20.
citation: Punt CD, Boer WE. Cardiac arrest following injection of concentrated trisodium citrate. Clin Nephrol. 2008 Apr;69(4):317-8. doi: 10.5414/cnp69317. No abstract available.
citation: Power A, Duncan N, Singh SK, Brown W, Dalby E, Edwards C, Lynch K, Prout V, Cairns T, Griffith M, McLean A, Palmer A, Taube D. Sodium citrate versus heparin catheter locks for cuffed central venous catheters: a single-center randomized controlled trial. Am J Kidney Dis. 2009 Jun;53(6):1034-41. doi: 10.1053/j.ajkd.2009.01.259. Epub 2009 Apr 25.
citation: Bonkain F, Racape J, Goncalvez I, Moerman M, Denis O, Gammar N, Gastaldello K, Nortier JL. Prevention of tunneled cuffed hemodialysis catheter-related dysfunction and bacteremia by a neutral-valve closed-system connector: a single-center randomized controlled trial. Am J Kidney Dis. 2013 Mar;61(3):459-65. doi: 10.1053/j.ajkd.2012.10.014. Epub 2012 Dec 8.