<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/NCT01687010</url>
  </required_header>
  <id_info>
    <org_study_id>PCT001</org_study_id>
    <nct_id>NCT01687010</nct_id>
  </id_info>
  <brief_title>Diagnostic and Prognostic Value of Combination Biomarkers in the Critically Ill Patient With Sepsis.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jianfeng Xie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Southeast University, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Southeast University, China</source>
  <brief_summary>
    <textblock>
      Sepsis is a common cause for morbidity and mortality in critically ill patients. With the&#xD;
      development of medical skills, the mortality is still remain very high. Inappropriateness of&#xD;
      initial antibiotic treatment is an important risk factor for mortality and effective&#xD;
      antimicrobial administration within the first hour of documented hypotension was associated&#xD;
      with increased survival to hospital discharge in adult patients with septic shock. However,&#xD;
      the early treatment based on early diagnosis.But it is very difficult to diagnosis because of&#xD;
      lack of specific clinic symptom and sign.When severe sepsis occur, biomarker could be helpful&#xD;
      to diagnosis. Unfortunately, the diagnostic value of single biomarker is limited. Therefore,&#xD;
      combine several biomarkers could enhance the diagnostic value.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2012</start_date>
  <completion_date type="Anticipated">October 2012</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Diagnostic and Predictive Value</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Critically ill patients admitted into ICU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age younger than 18 years&#xD;
&#xD;
          -  Refuse to participate in this study&#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>Jianfeng Xie, M.D.</last_name>
    <phone>+8602583272201</phone>
    <email>seuicu@yahoo.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Critical Care Medicine Nanjing Zhong-da Hospital Southeast University School of Medicine</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi Yang, M.D., Ph.D,</last_name>
      <phone>+8602583272202</phone>
      <email>yiyiyang2004@yahoo.com.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>September 17, 2012</last_update_submitted>
  <last_update_submitted_qc>September 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Jianfeng Xie</investigator_full_name>
    <investigator_title>Physician of critical care department</investigator_title>
  </responsible_party>
  <keyword>CRP, PCT, IL-6, Diagnosis, Prediction</keyword>
  <!-- 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/NCT01687010
org study id: PCT001
nct id: NCT01687010
lead sponsor: 
collaborator: 
Sepsis is a common cause for morbidity and mortality in critically ill patients. With the
      development of medical skills, the mortality is still remain very high. Inappropriateness of
      initial antibiotic treatment is an important risk factor for mortality and effective
      antimicrobial administration within the first hour of documented hypotension was associated
      with increased survival to hospital discharge in adult patients with septic shock. However,
      the early treatment based on early diagnosis.But it is very difficult to diagnosis because of
      lack of specific clinic symptom and sign.When severe sepsis occur, biomarker could be helpful
      to diagnosis. Unfortunately, the diagnostic value of single biomarker is limited. Therefore,
      combine several biomarkers could enhance the diagnostic value.
time perspective: Prospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jianfeng Xie, M.D.
phone: +8602583272201
email: seuicu@yahoo.com.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Southeast University, China
investigator full name: Jianfeng Xie
investigator title: Physician of critical care department