<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/NCT03802136</url>
  </required_header>
  <id_info>
    <org_study_id>2018062</org_study_id>
    <nct_id>NCT03802136</nct_id>
  </id_info>
  <brief_title>Multiple Biomarkers in ICU Sepsis Patients</brief_title>
  <official_title>Prognostic Value of Early Oxidative Stress Biomarkers in Patients With Sepsis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhongnan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhongnan Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Acute kidney injury (AKI) is a common condition among sepsis patients in the intensive care&#xD;
      unit (ICU) and is associated with high morbidity and mortality. Oxidative stress biomarkers&#xD;
      were investigated in panels and were reported to predict renal failure in sepsis patients.&#xD;
      Some biomarkers would be able to identify who will recover and not recover better than serum&#xD;
      creatinine. Thus, a combining oxidative stress biomarkers are needed to predict the&#xD;
      occurrence or progression of AKI in critically ill patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute kidney injury (AKI) is a common condition among sepsis patients in the intensive care&#xD;
      unit (ICU) and is associated with high morbidity and mortality. Oxidative stress biomarkers&#xD;
      were investigated in panels and were reported to predict renal failure in sepsis patients.&#xD;
      Research on AKI has focused on new damage biomarkers for early detection of AKI and worsening&#xD;
      of renal function. Some biomarkers would be able to identify who will recover and not recover&#xD;
      better than serum creatinine. Thus, a combining functional and damage markers as well as&#xD;
      oxidative stress biomarkers are needed to predict the occurrence or progression of AKI in&#xD;
      critically ill patients. Therefore, this prospective, observational study will be conducted&#xD;
      in Mainland China&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 30, 2018</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</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>presence of AKI</measure>
    <time_frame>a week after admission to ICU</time_frame>
    <description>Use serum creatinine or urine output（The KDIGO Guidelines 2012) to asess whether AKI happens to the studied subjects within a week after admission to ICU</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death of the patients</measure>
    <time_frame>2 weeks after admission to ICU</time_frame>
    <description>Mortality of the studied patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Use serum creatinine to assess renal function of the patients</measure>
    <time_frame>the 1 day when the patients admitted to ICU</time_frame>
    <description>Concetration of serum creatinine</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Sepsis, Severe</condition>
  <condition>Sepsis</condition>
  <condition>Septic Shock</condition>
  <condition>AKI</condition>
  <arm_group>
    <arm_group_label>high concentration of biomarkers</arm_group_label>
    <description>the patients with biomarkers level over the normal max value</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low concentration of biomarkers</arm_group_label>
    <description>the patients with biomarkers level below the normal max value</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum and centrifuged urine will be retained in a -80℃ fridge&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients admitted to ICU of Zhongnan Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  sepsis patients in appropriate age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ever blood transfusion ever CPR（cardiopulmonary resuscitation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>zhiyong peng, professor</last_name>
    <role>Study Director</role>
    <affiliation>Zhongnan Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>zhiyong peng, professor</last_name>
    <phone>008618672396028</phone>
    <email>pengzy5@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Li He</last_name>
    <phone>008617798258617</phone>
    <email>helisoul@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zhongnan Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>zhiyong peng, professor</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhongnan Hospital</investigator_affiliation>
    <investigator_full_name>ZhiYong Peng</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>AKI</keyword>
  <keyword>Sepsis</keyword>
  <keyword>Biomarker</keyword>
  <keyword>renal function</keyword>
  <keyword>oxidative stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</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/NCT03802136
org study id: 2018062
nct id: NCT03802136
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Acute kidney injury (AKI) is a common condition among sepsis patients in the intensive care
      unit (ICU) and is associated with high morbidity and mortality. Oxidative stress biomarkers
      were investigated in panels and were reported to predict renal failure in sepsis patients.
      Some biomarkers would be able to identify who will recover and not recover better than serum
      creatinine. Thus, a combining oxidative stress biomarkers are needed to predict the
      occurrence or progression of AKI in critically ill patients.
Acute kidney injury (AKI) is a common condition among sepsis patients in the intensive care
      unit (ICU) and is associated with high morbidity and mortality. Oxidative stress biomarkers
      were investigated in panels and were reported to predict renal failure in sepsis patients.
      Research on AKI has focused on new damage biomarkers for early detection of AKI and worsening
      of renal function. Some biomarkers would be able to identify who will recover and not recover
      better than serum creatinine. Thus, a combining functional and damage markers as well as
      oxidative stress biomarkers are needed to predict the occurrence or progression of AKI in
      critically ill patients. Therefore, this prospective, observational study will be conducted
      in Mainland China
observational model: Cohort
time perspective: Prospective
measure: presence of AKI
time frame: a week after admission to ICU
description: Use serum creatinine or urine output（The KDIGO Guidelines 2012) to asess whether AKI happens to the studied subjects within a week after admission to ICU
measure: Death of the patients
time frame: 2 weeks after admission to ICU
description: Mortality of the studied patients
measure: Use serum creatinine to assess renal function of the patients
time frame: the 1 day when the patients admitted to ICU
description: Concetration of serum creatinine
arm group label: high concentration of biomarkers
description: the patients with biomarkers level over the normal max value
arm group label: low concentration of biomarkers
description: the patients with biomarkers level below the normal max value
serum and centrifuged urine will be retained in a -80℃ fridge
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: zhiyong peng, professor
role: Study Director
affiliation: Zhongnan Hospital
last name: zhiyong peng, professor
phone: 008618672396028
email: pengzy5@hotmail.com
last name: Li He
phone: 008617798258617
email: helisoul@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhongnan Hospital
investigator full name: ZhiYong Peng
investigator title: professor
mesh term: Sepsis
mesh term: Toxemia