NCT01689753

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
Last Updated

September 26, 2012

Status Verified

September 1, 2012

Enrollment Period

1.1 years

First QC Date

July 23, 2012

Last Update Submit

September 25, 2012

Conditions

Other Complication of Vascular Dialysis Catheter

Keywords

Renal dialyseCatheter, indwellingCatheter-related infection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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%.

Device: TEGO connector®

Trisodium citrate

ACTIVE COMPARATOR

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

Drug: Trisodium citrate

Interventions

TEGO connector®DEVICE
TEGO® connector
Trisodium citrateDRUG
Also known as: Citralock®
Trisodium citrate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Mature arterio-venous fistula
  • Episode of TCC-related bacteremia 1 week before randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme Hospital

Anderlecht, Brussels Capital, 1070, Belgium

Location

Related Publications (10)

  • 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.

    PMID: 16813989RESULT

  • 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.

    PMID: 15151255RESULT

  • 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.

    PMID: 16033861RESULT

  • 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.

    PMID: 12454232RESULT

  • 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.

    PMID: 17597088RESULT

  • 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.

    PMID: 19948873RESULT

  • 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.

    PMID: 16627606RESULT

  • 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.

    PMID: 18397711RESULT

  • 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.

    PMID: 19394731RESULT

  • 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.

    PMID: 23228946DERIVED

MeSH Terms

Conditions

Catheter-Related Infections

Interventions

trisodium citrate

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Joëlle Nortier, MD, PhD

    Nephrology Dept, Erasme Hospital. Université Libre de Bruxelles, Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 23, 2012

First Posted

September 21, 2012

Study Start

March 1, 2009

Primary Completion

April 1, 2010

Study Completion

March 1, 2011

Last Updated

September 26, 2012

Record last verified: 2012-09

Locations

BE(1)