Effect of the TEGO Connector in Preventing Tunneled Cuffed Hemodialysis Catheters From Dysfunction and/or Bacteremia
NCT ID: NCT01689753
Last Updated: 2012-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2009-03-31
2011-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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TEGO® connector
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%.
TEGO connector®
Trisodium citrate
After each dialysis, the dead space of the catheter is filled with trisodium citrate 46.7% (Citralock®).
Trisodium citrate
Interventions
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TEGO connector®
Trisodium citrate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tunneled cuffed catheter providing a mean blood flow superior to 250 ml/min
* Patients having signed an informed consent
Exclusion Criteria
* Episode of TCC-related bacteremia 1 week before randomization
18 Years
ALL
No
Sponsors
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Erasme University Hospital
OTHER
Responsible Party
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Joëlle Nortier, MD, PhD
MD, PhD
Principal Investigators
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Joëlle Nortier, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Nephrology Dept, Erasme Hospital. Université Libre de Bruxelles, Brussel
Locations
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Erasme Hospital
Anderlecht, Brussels Capital, Belgium
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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P2009/021
Identifier Type: -
Identifier Source: org_study_id