xml: <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/NCT06019897</url>
    </required_header>
    <id_info>
      <org_study_id>202300052</org_study_id>
      <nct_id>NCT06019897</nct_id>
    </id_info>
    <brief_title>Impact of Tubing Colonization on the Incidence of Central Venous Catheter Infection</brief_title>
    <acronym>CRIC</acronym>
    <official_title>Impact of Tubing Colonization on the Incidence of Central Venous Catheter Infection. Observational Study CRIC (Colonisation Des Rampes et Infection de Cathéters)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Angers</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Angers</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this study is to assess the relationship between infusion system&#xD;
        colonization (ramps or multi-lumen devices) and the occurrence of CVC infection/colonization.&#xD;
  &#xD;
        This study is a prospective observational research that does not alter patient management.&#xD;
        Its objective is to evaluate the relationship between infusion tubing colonization and the&#xD;
        occurrence of central venous catheter infections.&#xD;
  &#xD;
        The only additional intervention is swabbing the taps at each ramp change (every 4 days) and&#xD;
        at catheter removal. For the multi-lumen device, swabbing is only performed upon catheter&#xD;
        removal at the level of the one-way valves.&#xD;
  &#xD;
        After catheter removal, a flush (1 mL of 0.9% NaCl) of the midline is performed and cultured&#xD;
        to assess for endoluminal colonization. The distal end of the CVC is sent for culture,&#xD;
        following the usual practice of the department to monitor catheter colonization and&#xD;
        infections.&#xD;
  &#xD;
        The primary outcome measure is the proportion of colonized infusion systems based on the&#xD;
        infection status of the CVC.&#xD;
  &#xD;
        The secondary objectives are to describe factors associated with CVC infections, determine&#xD;
        the incidence of colonization and infections in different locations of central venous&#xD;
        catheters, analyze the bacterial ecology based on the type of infusion system used, and&#xD;
        evaluate the ecological and economic impact of different devices (ramps vs. multi-lumen&#xD;
        devices).&#xD;
  &#xD;
        The secondary outcome measures are as follows:&#xD;
  &#xD;
        Proportion of colonized infusion systems based on the colonization status of the CVC and the&#xD;
        type of infusion system (ramps vs. multi-lumen devices) Proportion of colonized infusion&#xD;
        systems based on the infection status of the CVC and the type of infusion system (ramps vs.&#xD;
        multi-lumen devices) Duration of antibiotic treatment Weight of compounds used with each&#xD;
        infusion system over the duration of CVC placement (ramps vs. multi-lumen devices)&#xD;
        Calculation of material costs based on the infusion system used over the duration of CVC&#xD;
        placement (ramps vs. multi-lumen devices)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Central venous catheters (CVCs) are essential devices in the care of critically ill patients,&#xD;
        with approximately 63% of patients admitted to intensive care being exposed to them. While&#xD;
        they provide a safe access route for administering catecholamines or other substances&#xD;
        unsuitable for peripheral veins, they are also associated with complications, including&#xD;
        thrombotic and infectious events. CVC-related infections rank as the third most common&#xD;
        nosocomial infections in the intensive care unit, posing a major public health challenge.&#xD;
        According to the latest surveillance report on nosocomial infections in France, the incidence&#xD;
        density is 0.61 infections per 1,000 catheter-days and 0.49 catheter-related bloodstream&#xD;
        infections per 1,000 catheter-days. Approximately 10% of cultured catheters are found to be&#xD;
        positive, indicating colonization. These infections are associated with an increased risk of&#xD;
        mortality in the intensive care unit, estimated between 4% and 20%, as well as a prolonged&#xD;
        length of stay (5-20 days) and an additional cost of approximately €10,000 per episode.&#xD;
        Although catheter colonization has limited clinical impact, it remains a major concern due to&#xD;
        its role as a precursor to infection. CVC infection is defined by the presence of&#xD;
        microorganisms on the internal and/or external surface of the catheter, causing local and/or&#xD;
        systemic infection with or without bacteremia. There are several mechanisms of infection.&#xD;
        Traditionally, it is believed that infection begins with cutaneous colonization of the CVC,&#xD;
        which can then spread to the intravascular part of the catheter. Another cause of infection&#xD;
        is the colonization of infusion pathways leading to catheter colonization and infection&#xD;
        through the &quot;endoluminal&quot; route. Factors associated with CVC infection include the frequency&#xD;
        of line manipulations and the infused products. Therefore, it is recommended to minimize line&#xD;
        manipulations, adhere to strict aseptic measures when accessing infusion lines, and regularly&#xD;
        change (every 4 days) the infusion systems (ramps). Placing injection sites further away from&#xD;
        the insertion site reduces the risk of contamination. The first connector tubing is not&#xD;
        changed throughout the entire duration of CVC placement. However, there is limited recent&#xD;
        data confirming the link between infusion pathway colonization (particularly ramps used in&#xD;
        intensive care) and catheter infection. The equipment used as infusion systems has evolved&#xD;
        with the introduction of new devices, such as multi-lumen devices. One of these devices&#xD;
        consists of five injection ports, each equipped with one-way valves, connected to a separate&#xD;
        compartment in the tubing system, allowing simultaneous intravenous administration of five&#xD;
        different active substances without mixing. This device is left in place for the entire&#xD;
        duration of CVC placement (compared to current systems that are changed every 4 days). The&#xD;
        objective of this study is to investigate whether there is a relationship between the&#xD;
        colonization of infusion systems (ramps and/or multi-lumen devices) and the occurrence of CVC&#xD;
        infection/colonization, and if this relationship varies depending on the type of device used&#xD;
        (ramps vs. multi-lumen devices).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of central venous catheter infection according to the status colonized or not of the tubing</measure>
      <time_frame>up to Catheter removal or up to 6 weeks</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of days with antibiotics</measure>
      <time_frame>up to Catheter removal or up to 6 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of colonization and infection of central venous catheter according to their site</measure>
      <time_frame>up to Catheter removal</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of central venous catheter colonization according to the colonization of tubing and to the use or not of a multi lumen device</measure>
      <time_frame>up to catheter removal or up to 6 weeks</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Catheter-Related Infections</condition>
    <condition>Catheter Complications</condition>
    <condition>Catheter Infection</condition>
    <condition>Catheter-related Bloodstream Infection</condition>
    <condition>Catheter Related Complication</condition>
    <eligibility>
      <study_pop>
        <textblock>
          All patients admitted in a surgical intensive care unit and requiring a central venous&#xD;
          catheter for drug administration&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults &gt; 18 years old&#xD;
  &#xD;
            -  Admitted in Surgical Intensive Care unit&#xD;
  &#xD;
            -  Requiring a central venous catheter for more than 48h for drug administration (central&#xD;
               venous catheter for renal replacement therapy are excluded)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients &lt; 18 years old&#xD;
  &#xD;
            -  Patients under legal protection&#xD;
  &#xD;
            -  Patients who refuse the use of their data&#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_contact>
      <last_name>Maëva CAMPFORT, CCA</last_name>
      <phone>+33762755425</phone>
      <email>maevacampfort@gmail.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Catheter related infection</keyword>
    <keyword>catheter colonization</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Sepsis</mesh_term>
      <mesh_term>Catheter-Related Infections</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019897
  org study id: 202300052
  nct id: NCT06019897
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to assess the relationship between infusion system
        colonization (ramps or multi-lumen devices) and the occurrence of CVC infection/colonization.
  
        This study is a prospective observational research that does not alter patient management.
        Its objective is to evaluate the relationship between infusion tubing colonization and the
        occurrence of central venous catheter infections.
  
        The only additional intervention is swabbing the taps at each ramp change (every 4 days) and
        at catheter removal. For the multi-lumen device, swabbing is only performed upon catheter
        removal at the level of the one-way valves.
  
        After catheter removal, a flush (1 mL of 0.9% NaCl) of the midline is performed and cultured
        to assess for endoluminal colonization. The distal end of the CVC is sent for culture,
        following the usual practice of the department to monitor catheter colonization and
        infections.
  
        The primary outcome measure is the proportion of colonized infusion systems based on the
        infection status of the CVC.
  
        The secondary objectives are to describe factors associated with CVC infections, determine
        the incidence of colonization and infections in different locations of central venous
        catheters, analyze the bacterial ecology based on the type of infusion system used, and
        evaluate the ecological and economic impact of different devices (ramps vs. multi-lumen
        devices).
  
        The secondary outcome measures are as follows:
  
        Proportion of colonized infusion systems based on the colonization status of the CVC and the
        type of infusion system (ramps vs. multi-lumen devices) Proportion of colonized infusion
        systems based on the infection status of the CVC and the type of infusion system (ramps vs.
        multi-lumen devices) Duration of antibiotic treatment Weight of compounds used with each
        infusion system over the duration of CVC placement (ramps vs. multi-lumen devices)
        Calculation of material costs based on the infusion system used over the duration of CVC
        placement (ramps vs. multi-lumen devices)
  Central venous catheters (CVCs) are essential devices in the care of critically ill patients,
        with approximately 63% of patients admitted to intensive care being exposed to them. While
        they provide a safe access route for administering catecholamines or other substances
        unsuitable for peripheral veins, they are also associated with complications, including
        thrombotic and infectious events. CVC-related infections rank as the third most common
        nosocomial infections in the intensive care unit, posing a major public health challenge.
        According to the latest surveillance report on nosocomial infections in France, the incidence
        density is 0.61 infections per 1,000 catheter-days and 0.49 catheter-related bloodstream
        infections per 1,000 catheter-days. Approximately 10% of cultured catheters are found to be
        positive, indicating colonization. These infections are associated with an increased risk of
        mortality in the intensive care unit, estimated between 4% and 20%, as well as a prolonged
        length of stay (5-20 days) and an additional cost of approximately €10,000 per episode.
        Although catheter colonization has limited clinical impact, it remains a major concern due to
        its role as a precursor to infection. CVC infection is defined by the presence of
        microorganisms on the internal and/or external surface of the catheter, causing local and/or
        systemic infection with or without bacteremia. There are several mechanisms of infection.
        Traditionally, it is believed that infection begins with cutaneous colonization of the CVC,
        which can then spread to the intravascular part of the catheter. Another cause of infection
        is the colonization of infusion pathways leading to catheter colonization and infection
        through the "endoluminal" route. Factors associated with CVC infection include the frequency
        of line manipulations and the infused products. Therefore, it is recommended to minimize line
        manipulations, adhere to strict aseptic measures when accessing infusion lines, and regularly
        change (every 4 days) the infusion systems (ramps). Placing injection sites further away from
        the insertion site reduces the risk of contamination. The first connector tubing is not
        changed throughout the entire duration of CVC placement. However, there is limited recent
        data confirming the link between infusion pathway colonization (particularly ramps used in
        intensive care) and catheter infection. The equipment used as infusion systems has evolved
        with the introduction of new devices, such as multi-lumen devices. One of these devices
        consists of five injection ports, each equipped with one-way valves, connected to a separate
        compartment in the tubing system, allowing simultaneous intravenous administration of five
        different active substances without mixing. This device is left in place for the entire
        duration of CVC placement (compared to current systems that are changed every 4 days). The
        objective of this study is to investigate whether there is a relationship between the
        colonization of infusion systems (ramps and/or multi-lumen devices) and the occurrence of CVC
        infection/colonization, and if this relationship varies depending on the type of device used
        (ramps vs. multi-lumen devices).
  observational model: Cohort
  time perspective: Prospective
  measure: Incidence of central venous catheter infection according to the status colonized or not of the tubing
  time frame: up to Catheter removal or up to 6 weeks
  measure: Number of days with antibiotics
  time frame: up to Catheter removal or up to 6 weeks
  measure: Incidence of colonization and infection of central venous catheter according to their site
  time frame: up to Catheter removal
  measure: Incidence of central venous catheter colonization according to the colonization of tubing and to the use or not of a multi lumen device
  time frame: up to catheter removal or up to 6 weeks
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Maëva CAMPFORT, CCA
  phone: +33762755425
  email: maevacampfort@gmail.com
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Sepsis
  mesh term: Catheter-Related Infections