<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/NCT03803813</url>
  </required_header>
  <id_info>
    <org_study_id>JZhou</org_study_id>
    <nct_id>NCT03803813</nct_id>
  </id_info>
  <brief_title>Incidence of Sepsis After Craniocerebral Operation</brief_title>
  <official_title>The Incidence and Outcome of Sepsis After Craniocerebral Operation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jianfang Zhou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tiantan 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>
      To investigate the incidence and outcome of sepsis in critical patients undergoing&#xD;
      craniotomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective cohort study aiming to describe the incidence and outcome of sepsis in&#xD;
      critical patients undergoing craniotomy. This study has been approved by the institutional&#xD;
      review board of Beijing Tiantan hospital, and the need for informed consent was waived.&#xD;
&#xD;
      All patients over 18 years of age in intensive care will be screened for sepsis at admission&#xD;
      or during their ICU stay, whereas those who stay in the ICU for &lt;24 hrs for routine&#xD;
      postoperative surveillance will be excluded. Patients readmitted into ICU and have been&#xD;
      included at their first admission will not be included for a second time. Each center has one&#xD;
      or more investigators who are residents of intensive care medicine and responsible for&#xD;
      screening, patient records, and follow-up. They all have received at least one year of&#xD;
      clinical training in critical care medicine and had previous research experience.&#xD;
&#xD;
      Sepsis and septic shock are diagnosed according to the sepsis 3.0 criteria. Acute organ&#xD;
      dysfunction is defined as a Sequential Organ Failure Assessment (SOFA) score of 2 for the&#xD;
      organ in question. The causal relationship between sepsis and organ dysfunction is confirmed&#xD;
      based on medical recording and communication between the investigators and related ICU&#xD;
      physicians. Infection is defined by the attending physicians as the presence of&#xD;
      polymorphonuclear cells in a normally sterile body fluid(except blood),positive culture or&#xD;
      Gram stain of a normally sterile body fluid or tissue, unquestionable clinical signs of&#xD;
      infection, such as fecal peritonitis, necrotizing fasciitis, wound with purulent discharge,&#xD;
      et al, or clinical suspected infection with corresponding antibiotic treatment. ICU-acquired&#xD;
      infection is defined as infection identified 48 hours after ICU admission. Antibiotic&#xD;
      consociation application is defined as the daily administration of more than one kind of the&#xD;
      following antibiotics: penicillins, cephalosporins, carbapenem, macrolides, glycopeptides,&#xD;
      aminoglycosides, quinolones, sulfonamides, and other antibiotics.&#xD;
&#xD;
      For patients developing sepsis at ICU admission or during their ICU stay, the following data&#xD;
      will be collected using preprinted case report forms: age, sex, primary diagnosis, chronic&#xD;
      comorbidities, clinical and laboratory data for admission Acute Physiology and Chronic Health&#xD;
      Evaluation (APACHE) II and SOFA score, clinical and laboratory data for maximum SOFA score,&#xD;
      microbiological and clinical infectious information, occurrence of ICU-acquired infection,&#xD;
      antibiotics administered, hospital length of stay (LOS), ICU LOS, hospital costs, and&#xD;
      outcome. For patients who have not developed severe sepsis at ICU admission or during the ICU&#xD;
      stay, only age, sex, primary diagnosis, chronic comorbidities, ICU LOS, and outcome will be&#xD;
      recorded. If a patient has more than one episode that meet the criteria, only the data from&#xD;
      the first episode will be included in the study.&#xD;
&#xD;
      All recorded data will be screened in details by medical personnel for any missing&#xD;
      information, logical errors, or insufficient details.&#xD;
&#xD;
      Continuous variables were expressed as mean (SD) and analyzed by unpaired Student's t test.&#xD;
      Nonparametric variables were expressed as median and 25-75% percentiles and analyzed by the&#xD;
      Mann-Whitney test. Categorical variables were expressed as absolute (n) and relative (%)&#xD;
      frequency and were analyzed by chi-square test, as appropriate. p &lt; 0.05 was considered&#xD;
      statistically significant for all comparisons. SPSS version 19.0 for windows software was&#xD;
      used for the statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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 sepsis</measure>
    <time_frame>28 days</time_frame>
    <description>The incidence of sepsis in critical patients undergoing craniotomy</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">907</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>sepsis group</arm_group_label>
    <description>Patients have developed sepsis at ICU admission or during their ICU stay.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-sepsis group</arm_group_label>
    <description>Patients do not develope sepsis at ICU admission or during their ICU stay.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients over 18 years of age and have undergone craniotomy in intensive care will be&#xD;
        screened for sepsis at admission or during their ICU stay, whereas those who stay in the&#xD;
        ICU for &lt;24 hrs for routine postoperative surveillance will be excluded.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  ICU length of stay ≥ 24 hours&#xD;
&#xD;
          -  after craniotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years&#xD;
&#xD;
          -  ICU length of stay &lt; 24 hours&#xD;
&#xD;
          -  Patients or their immediate family members refuse to participate in the research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jian-Xin Zhou, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Beijing Tiantan Hospital, Capital Medical Universtity</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Tian Tan hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tiantan Hospital</investigator_affiliation>
    <investigator_full_name>Jianfang Zhou</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>sepsis</keyword>
  <keyword>septic shock</keyword>
  <keyword>infection</keyword>
  <keyword>craniotomy</keyword>
  <keyword>outcome</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>
  <patient_data>
    <sharing_ipd>No</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/NCT03803813
org study id: JZhou
nct id: NCT03803813
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To investigate the incidence and outcome of sepsis in critical patients undergoing
      craniotomy.
This is a prospective cohort study aiming to describe the incidence and outcome of sepsis in
      critical patients undergoing craniotomy. This study has been approved by the institutional
      review board of Beijing Tiantan hospital, and the need for informed consent was waived.

      All patients over 18 years of age in intensive care will be screened for sepsis at admission
      or during their ICU stay, whereas those who stay in the ICU for <24 hrs for routine
      postoperative surveillance will be excluded. Patients readmitted into ICU and have been
      included at their first admission will not be included for a second time. Each center has one
      or more investigators who are residents of intensive care medicine and responsible for
      screening, patient records, and follow-up. They all have received at least one year of
      clinical training in critical care medicine and had previous research experience.

      Sepsis and septic shock are diagnosed according to the sepsis 3.0 criteria. Acute organ
      dysfunction is defined as a Sequential Organ Failure Assessment (SOFA) score of 2 for the
      organ in question. The causal relationship between sepsis and organ dysfunction is confirmed
      based on medical recording and communication between the investigators and related ICU
      physicians. Infection is defined by the attending physicians as the presence of
      polymorphonuclear cells in a normally sterile body fluid(except blood),positive culture or
      Gram stain of a normally sterile body fluid or tissue, unquestionable clinical signs of
      infection, such as fecal peritonitis, necrotizing fasciitis, wound with purulent discharge,
      et al, or clinical suspected infection with corresponding antibiotic treatment. ICU-acquired
      infection is defined as infection identified 48 hours after ICU admission. Antibiotic
      consociation application is defined as the daily administration of more than one kind of the
      following antibiotics: penicillins, cephalosporins, carbapenem, macrolides, glycopeptides,
      aminoglycosides, quinolones, sulfonamides, and other antibiotics.

      For patients developing sepsis at ICU admission or during their ICU stay, the following data
      will be collected using preprinted case report forms: age, sex, primary diagnosis, chronic
      comorbidities, clinical and laboratory data for admission Acute Physiology and Chronic Health
      Evaluation (APACHE) II and SOFA score, clinical and laboratory data for maximum SOFA score,
      microbiological and clinical infectious information, occurrence of ICU-acquired infection,
      antibiotics administered, hospital length of stay (LOS), ICU LOS, hospital costs, and
      outcome. For patients who have not developed severe sepsis at ICU admission or during the ICU
      stay, only age, sex, primary diagnosis, chronic comorbidities, ICU LOS, and outcome will be
      recorded. If a patient has more than one episode that meet the criteria, only the data from
      the first episode will be included in the study.

      All recorded data will be screened in details by medical personnel for any missing
      information, logical errors, or insufficient details.

      Continuous variables were expressed as mean (SD) and analyzed by unpaired Student's t test.
      Nonparametric variables were expressed as median and 25-75% percentiles and analyzed by the
      Mann-Whitney test. Categorical variables were expressed as absolute (n) and relative (%)
      frequency and were analyzed by chi-square test, as appropriate. p < 0.05 was considered
      statistically significant for all comparisons. SPSS version 19.0 for windows software was
      used for the statistical analysis.
observational model: Cohort
time perspective: Prospective
measure: Incidence of sepsis
time frame: 28 days
description: The incidence of sepsis in critical patients undergoing craniotomy
arm group label: sepsis group
description: Patients have developed sepsis at ICU admission or during their ICU stay.
arm group label: non-sepsis group
description: Patients do not develope sepsis at ICU admission or during their ICU stay.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Jian-Xin Zhou, MD
role: Study Chair
affiliation: Beijing Tiantan Hospital, Capital Medical Universtity
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Beijing Tiantan Hospital
investigator full name: Jianfang Zhou
investigator title: Principal Investigator
mesh term: Sepsis
mesh term: Toxemia
sharing ipd: No