<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/NCT03841240</url>
  </required_header>
  <id_info>
    <org_study_id>2018ZZJHZX003</org_study_id>
    <nct_id>NCT03841240</nct_id>
  </id_info>
  <brief_title>The Central Venous Catheter Related Complications in Critically Ill Patients</brief_title>
  <official_title>The Central Venous Catheter Related Complications in Critically Ill Patients: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhujiang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhujiang Hospital</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>
      In this prospective clinical study, the researchers investigate the incidence of&#xD;
      catheter-related thrombosis and catheter-related infection during indwelling central venous&#xD;
      catheterization in critically ill patients, and analyzed the risk factors for&#xD;
      catheter-related complications and the relationship between catheter-related thrombi and&#xD;
      catheter-related infections. The sample size is about 500.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective clinical trial is conducted. Five hundred participants who need to place&#xD;
      central venous catheters admit to the Department of Critical Care Medicine of Zhujiang&#xD;
      Hospital,Southern Medical University from February 2019. Ultrasound is used for screening&#xD;
      catheter-related thrombosis, and catheter-related infections are diagnosed according to the&#xD;
      Guidelines for the Diagnosis and Management of Intravascular Catheter-Related Infections. The&#xD;
      primary outcome is the incidence of catheter-related thrombosis and catheter-related&#xD;
      infections. The primary exposure factors are age, gender, APACHE II, RBC, Hct, PLT, FIB,&#xD;
      D-dimer, PCT, blood glucose, anticoagulants, and vasoactive drugs, catheter type, tube&#xD;
      placement, indwelling time, etc. Descriptive analysis is used for the incidence of various&#xD;
      complications. T-test or non-parametric statistical test is used for single factor analysis&#xD;
      of risk factors, chi-square test or Fisher's exact probability test is used for counting&#xD;
      data. Multivariate analysis of risk factors and the relationship between complications are&#xD;
      analyzed by logistic regression. Statistical analysis is performed with SPSS Statistics&#xD;
      version 20.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">February 19, 2019</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>The incidence of catheter-related complications</measure>
    <time_frame>Average 10 days</time_frame>
    <description>The incidence of catheter-related thrombosis and infections</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Catheter Thrombosis</condition>
  <condition>Catheter-Related Infections</condition>
  <condition>Central Venous Catheter Related Bloodstream Infection</condition>
  <condition>Central Venous Catheter Thrombosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population comes from the five critical medical wards of Zhujiang Hospital ,&#xD;
        including integrated area, cardiovascular severe ward, respiratory severe ward,&#xD;
        neurological severe ward and neurosurgical severe ward.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years old and &lt;80 years old;&#xD;
&#xD;
          -  Central venous catheter is required to be placed through the internal jugular vein,&#xD;
             subclavian vein or femoral vein;&#xD;
&#xD;
          -  Catheter placement is estimated to be ≥ 72 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The central venous catheter has been placed before entering the department;&#xD;
&#xD;
          -  There is obvious trauma or infection at the site of implantation;&#xD;
&#xD;
          -  There is already a blood vessel thrombus in the site before implantation;&#xD;
&#xD;
          -  Recently, deep vein thrombosis or catheter-related thrombosis has occurred.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510282</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>August 9, 2021</last_update_submitted>
  <last_update_submitted_qc>August 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>catheter</keyword>
  <keyword>thrombosis</keyword>
  <keyword>infection</keyword>
  <keyword>ultrasound</keyword>
  <keyword>risk factor</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>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Upper Extremity Deep Vein Thrombosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03841240
org study id: 2018ZZJHZX003
nct id: NCT03841240
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this prospective clinical study, the researchers investigate the incidence of
      catheter-related thrombosis and catheter-related infection during indwelling central venous
      catheterization in critically ill patients, and analyzed the risk factors for
      catheter-related complications and the relationship between catheter-related thrombi and
      catheter-related infections. The sample size is about 500.
A prospective clinical trial is conducted. Five hundred participants who need to place
      central venous catheters admit to the Department of Critical Care Medicine of Zhujiang
      Hospital,Southern Medical University from February 2019. Ultrasound is used for screening
      catheter-related thrombosis, and catheter-related infections are diagnosed according to the
      Guidelines for the Diagnosis and Management of Intravascular Catheter-Related Infections. The
      primary outcome is the incidence of catheter-related thrombosis and catheter-related
      infections. The primary exposure factors are age, gender, APACHE II, RBC, Hct, PLT, FIB,
      D-dimer, PCT, blood glucose, anticoagulants, and vasoactive drugs, catheter type, tube
      placement, indwelling time, etc. Descriptive analysis is used for the incidence of various
      complications. T-test or non-parametric statistical test is used for single factor analysis
      of risk factors, chi-square test or Fisher's exact probability test is used for counting
      data. Multivariate analysis of risk factors and the relationship between complications are
      analyzed by logistic regression. Statistical analysis is performed with SPSS Statistics
      version 20.
observational model: Cohort
time perspective: Prospective
measure: The incidence of catheter-related complications
time frame: Average 10 days
description: The incidence of catheter-related thrombosis and infections
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Sepsis
mesh term: Catheter-Related Infections
mesh term: Thrombosis
mesh term: Upper Extremity Deep Vein Thrombosis
sharing ipd: Undecided