<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01689753</url>
  </required_header>
  <id_info>
    <org_study_id>P2009/021</org_study_id>
    <nct_id>NCT01689753</nct_id>
  </id_info>
  <brief_title>Effect of the TEGO Connector in Preventing Tunneled Cuffed Hemodialysis Catheters From Dysfunction and/or Bacteremia</brief_title>
  <official_title>Prevention of Tunneled Cuffed Hemodialysis Catheter-Related Dysfunction and Bacteremia by the TEGO® Connector: A Single-Center Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasme University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erasme University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the trial was to assess whether use of the TEGO connector was able to reduce the&#xD;
      incidence of a composite endpoint of TCC-related dysfunction (TCC-D)or TCC-related bacteremia&#xD;
      (TCC-B) in chronic hemodialysis (HD) patients carrying the TEGO® connector vs controls&#xD;
      receiving trisodium citrate 46.7%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The TEGO® connector (ICU Medical, www.icumed.com) is a closed positive pressure system,&#xD;
      flushed with 0.9% sodium chloride and attached on the hubs of the TCC. As recommended by the&#xD;
      producer, the TEGO® remains during 3 consecutive HD sessions and is changed every week. By&#xD;
      constituting a mechanical barrier, it could be an interesting alternative to reduce the&#xD;
      intraluminal contamination and the risk of TCC-B.&#xD;
&#xD;
      The TEGO® connector is supposed to provide an automatic positive displacement of fluid at the&#xD;
      end of each TCC flush. This positive pressure could prevent the reflux of blood into the TCC&#xD;
      lumen, possibly resulting in TCC-D.&#xD;
&#xD;
      As the impact of the TEGO® connector on TCC-D and TCC-B has never been studied, we conducted&#xD;
      a randomized controlled study in our center by comparing the anti-thrombotic and&#xD;
      anti-infectious efficacy of the TEGO® connector to trisodium citrate 46.7% (Citralock®,&#xD;
      Dirinco, www.citra-lock.com) . The global cost of both procedures was also evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2009</start_date>
  <completion_date type="Actual">March 2011</completion_date>
  <primary_completion_date type="Actual">April 2010</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence rate of tunneled cuffed catheter-related dysfunction or bacteremia (composite endpoint)</measure>
    <time_frame>16 months</time_frame>
    <description>Tunneled cuffed catheter dysfunction was defined by the requirement of urokinase and/or a mean blood flow &lt; 250 ml/min during two consecutive hemodialysis sessions. Tunneled cuffed catheter bacteremia was defined by ≥ 2 positive qualitative and/or quantitative positive blood cultures.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Other Complication of Vascular Dialysis Catheter</condition>
  <arm_group>
    <arm_group_label>TEGO® connector</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trisodium citrate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After each dialysis, the dead space of the catheter is filled with trisodium citrate 46.7% (Citralock®).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TEGO connector®</intervention_name>
    <arm_group_label>TEGO® connector</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trisodium citrate</intervention_name>
    <arm_group_label>Trisodium citrate</arm_group_label>
    <other_name>Citralock®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult HD patients, prevalent or incident,carrying a tunneled cuffed catheter&#xD;
&#xD;
          -  Tunneled cuffed catheter providing a mean blood flow superior to 250 ml/min&#xD;
&#xD;
          -  Patients having signed an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mature arterio-venous fistula&#xD;
&#xD;
          -  Episode of TCC-related bacteremia 1 week before randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joëlle Nortier, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nephrology Dept, Erasme Hospital. Université Libre de Bruxelles, Brussel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erasme Hospital</name>
      <address>
        <city>Anderlecht</city>
        <state>Brussel</state>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>16813989</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>15151255</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>16033861</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>12454232</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>17597088</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>19948873</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>16627606</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>18397711</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>19394731</PMID>
  </results_reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>July 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 25, 2012</last_update_submitted>
  <last_update_submitted_qc>September 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasme University Hospital</investigator_affiliation>
    <investigator_full_name>Joëlle Nortier, MD, PhD</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Renal dialyse</keyword>
  <keyword>Catheter, indwelling</keyword>
  <keyword>Catheter-related infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacteremia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Citric Acid</mesh_term>
    <mesh_term>Sodium Citrate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01689753
org study id: P2009/021
nct id: NCT01689753
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence rate of tunneled cuffed catheter-related dysfunction or bacteremia (composite endpoint)
time frame: 16 months
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.
arm group label: TEGO® connector
arm group type: Experimental
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 group label: Trisodium citrate
arm group type: Active Comparator
description: After each dialysis, the dead space of the catheter is filled with trisodium citrate 46.7% (Citralock®).
intervention type: Device
intervention name: TEGO connector®
arm group label: TEGO® connector
intervention type: Drug
intervention name: Trisodium citrate
arm group label: Trisodium citrate
other name: Citralock®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joëlle Nortier, MD, PhD
role: Principal Investigator
affiliation: Nephrology Dept, Erasme Hospital. Université Libre de Bruxelles, Brussel
facility: 
country: Belgium
citation: 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: 16813989
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.
PMID: 15151255
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.
PMID: 16033861
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.
PMID: 12454232
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.
PMID: 17597088
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.
PMID: 19948873
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.
PMID: 16627606
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.
PMID: 18397711
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.
PMID: 19394731
responsible party type: Principal Investigator
investigator affiliation: Erasme University Hospital
investigator full name: Joëlle Nortier, MD, PhD
investigator title: MD, PhD
mesh term: Bacteremia
mesh term: Citric Acid
mesh term: Sodium Citrate