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

Primary Purpose

Other Complication of Vascular Dialysis Catheter

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
TEGO connector®
Trisodium citrate
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Other Complication of Vascular Dialysis Catheter focused on measuring Renal dialyse, Catheter, indwelling, Catheter-related infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erasme Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TEGO® connector

Trisodium citrate

Arm Description

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%.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 23, 2012
Last Updated
September 25, 2012
Sponsor
Erasme University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01689753
Brief Title
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

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasme University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Complication of Vascular Dialysis Catheter
Keywords
Renal dialyse, Catheter, indwelling, Catheter-related infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEGO® connector
Arm Type
Experimental
Arm Description
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%.
Arm Title
Trisodium citrate
Arm Type
Active Comparator
Arm Description
After each dialysis, the dead space of the catheter is filled with trisodium citrate 46.7% (Citralock®).
Intervention Type
Device
Intervention Name(s)
TEGO connector®
Intervention Type
Drug
Intervention Name(s)
Trisodium citrate
Other Intervention Name(s)
Citralock®
Primary Outcome Measure Information:
Title
Incidence rate of tunneled cuffed catheter-related dysfunction or bacteremia (composite endpoint)
Description
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.
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joëlle Nortier, MD, PhD
Organizational Affiliation
Nephrology Dept, Erasme Hospital. Université Libre de Bruxelles, Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasme Hospital
City
Anderlecht
State/Province
Brussel
ZIP/Postal Code
1070
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
16813989
Citation
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Results Reference
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PubMed Identifier
15151255
Citation
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.
Results Reference
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PubMed Identifier
16033861
Citation
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.
Results Reference
result
PubMed Identifier
12454232
Citation
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.
Results Reference
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PubMed Identifier
17597088
Citation
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.
Results Reference
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PubMed Identifier
19948873
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.
Results Reference
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PubMed Identifier
16627606
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.
Results Reference
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PubMed Identifier
18397711
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.
Results Reference
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PubMed Identifier
19394731
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.
Results Reference
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PubMed Identifier
23228946
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.
Results Reference
derived

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

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