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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%.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEGO® connector | 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%. |
|
| Trisodium citrate | Active Comparator | After each dialysis, the dead space of the catheter is filled with trisodium citrate 46.7% (Citralock®). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEGO connector® | Device |
| ||
| Trisodium citrate |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joëlle Nortier, MD, PhD | Nephrology Dept, Erasme Hospital. Université Libre de Bruxelles, Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme Hospital | Anderlecht | Brussels Capital | 1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16813989 | Result | Vascular Access 2006 Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S176-247. doi: 10.1053/j.ajkd.2006.04.029. No abstract available. | |
| 15151255 | Result | Di Iorio BR, Bellizzi V, Cillo N, Cirillo M, Avella F, Andreucci VE, De Santo NG. Vascular access for hemodialysis: the impact on morbidity and mortality. J Nephrol. 2004 Jan-Feb;17(1):19-25. |
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| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C514290 | trisodium citrate |
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| 16033861 | Result | Weijmer MC, van den Dorpel MA, Van de Ven PJ, ter Wee PM, van Geelen JA, Groeneveld JO, van Jaarsveld BC, Koopmans MG, le Poole CY, Schrander-Van der Meer AM, Siegert CE, Stas KJ; CITRATE Study Group. Randomized, clinical trial comparison of trisodium citrate 30% and heparin as catheter-locking solution in hemodialysis patients. J Am Soc Nephrol. 2005 Sep;16(9):2769-77. doi: 10.1681/ASN.2004100870. Epub 2005 Jul 20. |
| 12454232 | Result | Weijmer MC, Debets-Ossenkopp YJ, Van De Vondervoort FJ, ter Wee PM. Superior antimicrobial activity of trisodium citrate over heparin for catheter locking. Nephrol Dial Transplant. 2002 Dec;17(12):2189-95. doi: 10.1093/ndt/17.12.2189. |
| 17597088 | Result | Eloot S, De Vos JY, Hombrouckx R, Verdonck P. How much is catheter flow influenced by the use of closed luer lock access devices? Nephrol Dial Transplant. 2007 Oct;22(10):3061-4. doi: 10.1093/ndt/gfm314. Epub 2007 Jun 27. |
| 19948873 | Result | 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. |
| 16627606 | Result | 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. |
| 18397711 | Result | 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. |
| 19394731 | Result | 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. |
| 23228946 | Derived | 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. |