<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/NCT03270774</url>
  </required_header>
  <id_info>
    <org_study_id>CVC Study</org_study_id>
    <nct_id>NCT03270774</nct_id>
  </id_info>
  <brief_title>Central Venous Catheter Colonisation Among Critically Ill Patients in Intensive Care Units</brief_title>
  <official_title>Central Venous Catheter Colonisation: Prevalence and Associated Factors Among Critically Ill Patients Admitted to Ugandan Intensive Care Units</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makerere University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makerere University</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>
      Background: Central Venous catheter insertion technique and indwelling time are major risk&#xD;
      factors for CVC colonisation. Colonisation occurs through microbial migration and biofilm&#xD;
      formation along the catheter insertion tract. This study set out to determine the prevalence&#xD;
      and associated factors for central venous catheter colonisation among critically ill patient.&#xD;
      No data exists in this clinical setting addressing this topic.&#xD;
&#xD;
      Methods: The study population included 100 participants with central venous catheters in situ&#xD;
      for at least 24 hours. Catheter tip (distal 5-cm segment) and blood cultures (10mls&#xD;
      peripheral blood) were obtained at the time of catheter removal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction : Central venous catheter (CVC) insertion technique and time spent in situ&#xD;
      (dwell period) are major risk factors for CVC colonisation among patients admitted to&#xD;
      intensive care units (ICU) worldwide. Normal skin flora colonizes CVCs early in their dwell&#xD;
      period (&lt; 7-10 days) causing variable occurrence of infections in all categories of patients.&#xD;
      Uganda has no data on CVC colonisation and with increasing use there is concern of CVC&#xD;
      colonisation and its consequences. This study was done to determine the prevalence and&#xD;
      associated factors of CVC colonization among patients in general ICUs.&#xD;
&#xD;
      Methodology: This was prospective cohort study. Critically ill patients with CVCs in situ&#xD;
      from four general ICUs were consecutively enrolled into the study. Data on socio-demographic,&#xD;
      clinical characteristics (diagnosis, comorbidities) and CVC insertion (site, technique,&#xD;
      experience) was collected using a standardised questionnaire until a sample size of 100 was&#xD;
      achieved. At the time of CVC removal, the CVC tip (distal 5cm segment) was aseptically&#xD;
      obtained and cultured for microorganisms using the semi-quantitative method. A blood culture&#xD;
      sample (10mls) was also collected from a peripheral site at the same time. Data was double&#xD;
      entered into EPIDATA version 3.1.5 and exported to STATA version 12.0 for analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 19, 2016</start_date>
  <completion_date type="Actual">April 19, 2017</completion_date>
  <primary_completion_date type="Actual">April 10, 2017</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>Prevalence of central venous catheter colonisation</measure>
    <time_frame>up to 14 days</time_frame>
    <description>Of the patients that had central venous catheter inserted, how many of them developed central venous catheter colonisation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of Central venous catheter associated bloodstream infections</measure>
    <time_frame>Up to 48 hours after removal of central venous catheter</time_frame>
    <description>Of the patients that developed central venous catheter colonisation, how many of them developed associated bloodstream infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factors associated with central venous catheter colonisation</measure>
    <time_frame>up to 14 days</time_frame>
    <description>Factors that have a significant p-value &lt; 0.5 of association with central venous catheter colonisation</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Sepsis</condition>
  <condition>Septic Shock</condition>
  <condition>Post-cardiac Surgery</condition>
  <condition>Post-Cardiorespiratory Arrest Coma</condition>
  <condition>Head Injury</condition>
  <condition>Hypoxic Brain Damage</condition>
  <condition>Acute Liver Failure</condition>
  <condition>Diabetic Ketoacidotic Hyperglycaemic Coma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Study population All the critically ill patients with CVCs admitted to the general ICUs in&#xD;
        the 4 hospitals above during the study period and who met the inclusion criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of all age groups were included in this study&#xD;
&#xD;
          -  All critically ill patients admitted to the ICU with Central Venous Catheters in situ&#xD;
&#xD;
          -  Written informed consent/assent&#xD;
&#xD;
          -  Waiver of consent for unconscious patients with no attendant/valid surrogate&#xD;
             respondent to provide the required information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        •Patients who were already on treatment for CVC-related infectious complications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Failure</mesh_term>
    <mesh_term>Liver Failure, Acute</mesh_term>
    <mesh_term>Craniocerebral Trauma</mesh_term>
    <mesh_term>Coma</mesh_term>
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Hypoxia, Brain</mesh_term>
  </condition_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/NCT03270774
org study id: CVC Study
nct id: NCT03270774
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Central Venous catheter insertion technique and indwelling time are major risk
      factors for CVC colonisation. Colonisation occurs through microbial migration and biofilm
      formation along the catheter insertion tract. This study set out to determine the prevalence
      and associated factors for central venous catheter colonisation among critically ill patient.
      No data exists in this clinical setting addressing this topic.

      Methods: The study population included 100 participants with central venous catheters in situ
      for at least 24 hours. Catheter tip (distal 5-cm segment) and blood cultures (10mls
      peripheral blood) were obtained at the time of catheter removal.
Introduction : Central venous catheter (CVC) insertion technique and time spent in situ
      (dwell period) are major risk factors for CVC colonisation among patients admitted to
      intensive care units (ICU) worldwide. Normal skin flora colonizes CVCs early in their dwell
      period (< 7-10 days) causing variable occurrence of infections in all categories of patients.
      Uganda has no data on CVC colonisation and with increasing use there is concern of CVC
      colonisation and its consequences. This study was done to determine the prevalence and
      associated factors of CVC colonization among patients in general ICUs.

      Methodology: This was prospective cohort study. Critically ill patients with CVCs in situ
      from four general ICUs were consecutively enrolled into the study. Data on socio-demographic,
      clinical characteristics (diagnosis, comorbidities) and CVC insertion (site, technique,
      experience) was collected using a standardised questionnaire until a sample size of 100 was
      achieved. At the time of CVC removal, the CVC tip (distal 5cm segment) was aseptically
      obtained and cultured for microorganisms using the semi-quantitative method. A blood culture
      sample (10mls) was also collected from a peripheral site at the same time. Data was double
      entered into EPIDATA version 3.1.5 and exported to STATA version 12.0 for analysis.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of central venous catheter colonisation
time frame: up to 14 days
description: Of the patients that had central venous catheter inserted, how many of them developed central venous catheter colonisation
measure: Prevalence of Central venous catheter associated bloodstream infections
time frame: Up to 48 hours after removal of central venous catheter
description: Of the patients that developed central venous catheter colonisation, how many of them developed associated bloodstream infection
measure: Factors associated with central venous catheter colonisation
time frame: up to 14 days
description: Factors that have a significant p-value < 0.5 of association with central venous catheter colonisation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Liver Failure
mesh term: Liver Failure, Acute
mesh term: Craniocerebral Trauma
mesh term: Coma
mesh term: Brain Injuries
mesh term: Hypoxia, Brain