xml: <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/NCT05999682</url>
    </required_header>
    <id_info>
      <org_study_id>2023-KY-085-03</org_study_id>
      <nct_id>NCT05999682</nct_id>
    </id_info>
    <brief_title>Improvement of Organ Function by Apigenin in Elderly Patients With Sepsis</brief_title>
    <official_title>Improvement of Organ Function by Apigenin in Elderly Patients With Sepsis: A Single-center, Single-blind, Randomized, Placebo-controlled, Pilot Clinical Trial</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>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>
        In this single-center, randomized, single-blind, placebo-controlled pilot clinical trial. The&#xD;
        effect of apigenin on the improvement of organ function will be investigated in elderly&#xD;
        patients with sepsis. Researchers will screen patients admitted to the Department of Critical&#xD;
        Care Medicine at Zhujiang Hospital to identify patients with sepsis based on including and&#xD;
        excluding criteria and obtain informed consent and randomize them into groups. The treatment&#xD;
        group will be given apigenin tablets 50mg ground with 5ml of sterilized water for&#xD;
        intra-gastric tube injection; the control group will be given an equal volume of sterilized&#xD;
        water for intra-gastric tube injection. The changes in SOFA score and other clinically&#xD;
        meaningful outcomes in 4 days will be collected.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Investigational drug: Apigenin Study title: Improvement of Organ function by Apigenin in&#xD;
        Elderly Patients With Sepsis: A Single-center, Single-blind, Randomized, Placebo-controlled,&#xD;
        pilot Clinical Trial Principal Investigator: Zhanguo Liu, professor, Department of Critical&#xD;
        Care Medicine, Zhujiang Hospital, Southern Medical University Study subjects: Elderly&#xD;
        septic/septic shock patients who meet the diagnostic criteria of the 2016 International&#xD;
        Sepsis Guidelines.&#xD;
  &#xD;
        Study objectives: The objective of the study is to determine whether apigenin, compared to&#xD;
        placebo, improves organ dysfunction scores (SOFA scores) in elderly septic patients.&#xD;
  &#xD;
        Study design: A single-center, single-blind, randomized, placebo-controlled pilot Clinical&#xD;
        Trial.&#xD;
  &#xD;
        Method: Apigenin group: Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml&#xD;
        of sterilized water + conventional standardized treatment, for 4 days or until ICU discharge.&#xD;
        Placebo control group: Gastric tube injection of 5 ml of sterilized water for injection +&#xD;
        conventional standardized treatment, for 4 days or ICU discharge.&#xD;
  &#xD;
        Course: 4 days Sample size: 20 The number of study center: 1&#xD;
  &#xD;
        Study center:&#xD;
  &#xD;
          1. Department of Critical Care Medicine of Zhujiang Hospital, Guangzhou, Guangdong, China&#xD;
             Primary endpoint: 96-hour Sequential Organ Failure Assessment (SOFA) score&#xD;
  &#xD;
             Secondary endpoints:&#xD;
  &#xD;
          2. The state of inflammatory response: the serum level of interleukin-6(IL-6) and&#xD;
             C-reactive protein (CRP) at 96 h after randomization.&#xD;
  &#xD;
          3. The state of liver function: the serum level of transaminase (AST#ALT) #total bilirubin&#xD;
             at 96 h after randomization.&#xD;
  &#xD;
          4. The state of lung function: oxygenation index (PaO2/FiO2) at 96h after Randomization.&#xD;
  &#xD;
          5. The state of kidney function: the serum level of Creatinine (Cr)#blood urea nitrogen&#xD;
             (BUN)# at 96 h after randomization.&#xD;
  &#xD;
          6. The state of infection: the serum level of procalcitonin (PCT) at 96 h after&#xD;
             randomization.&#xD;
  &#xD;
          7. The state of circulation system: the serum level of lactate at 96 h after Randomization.&#xD;
  &#xD;
          8. The duration of successful cessation of supportive therapies for organ dysfunction&#xD;
             including vasoactive agents, mechanical ventilation.&#xD;
  &#xD;
          9. The daily urine output#duration of continuous renal replacement therapy (CRRT) #fluid&#xD;
             balance.&#xD;
  &#xD;
         10. The length of stay in ICU.&#xD;
  &#xD;
        Safety endpoints:&#xD;
  &#xD;
          1. adverse events&#xD;
  &#xD;
          2. Serious adverse events&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Treatment group: Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 days or ICU discharge.&#xD;
  Control group: Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 days or ICU discharge.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Single(Participant)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>96-hour Sequential Organ Failure Assessment (SOFA) score</measure>
      <time_frame>The outcome will be assessed at the 0,1,2,3,4 day after enrollment</time_frame>
      <description>The SOFA score is the Sequential Organ Failure Score, which is used to assess a patient's prognosis by determining the degree of impairment of major organ function. The score is divided into 6 sections: respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal, and ranges from 0 to 4, with higher SOFA scores associated with a higher incidence of poor prognosis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>inflammatory response(1)</measure>
      <time_frame>The outcome will be assessed at the 0,1,2,3,4 day after enrollment</time_frame>
      <description>the serum level of C-reactive protein(CRP)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>inflammatory response(2)</measure>
      <time_frame>The outcome will be assessed at the 0,1,2,3,4 day after enrollment</time_frame>
      <description>the serum level of interleukin-6(IL-6)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of use of vasoactive drugs</measure>
      <time_frame>The outcome will be assessed at the 0,1,2,3,4 day after enrollment</time_frame>
      <description>The duration from the vasoactive drugs administration to the successful cessation in hours( The successful cessation is defined as the attainment of a clinician-prescribed mean arterial pressure target for more than 24-hours without the use of vasoactive drugs.This outcome measure is intended only for patients receiving vasoactive drugs)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>liver function(1)</measure>
      <time_frame>The outcome will be assessed at the 0,1,2,3,4 day after enrollment</time_frame>
      <description>the serum level of Alanine transaminase(ALT)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>liver function(2)</measure>
      <time_frame>The outcome will be assessed at the 0,1,2,3,4 day after enrollment</time_frame>
      <description>the serum level of Aspartate transaminase (AST)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>liver function(3)</measure>
      <time_frame>The outcome will be assessed at the 0,1,2,3,4 day after enrollment</time_frame>
      <description>the serum level of total bilirubin(TBil)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lung function</measure>
      <time_frame>The outcome will be assessed at the 0,1,2,3,4 day after enrollment</time_frame>
      <description>oxygenation index(PaO2/FiO2),the patients treated with extracorporeal membrane oxygenation will not collect this indicator</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>kidney function(1)</measure>
      <time_frame>The outcome will be assessed at the 0,1,2,3,4 day after enrollment</time_frame>
      <description>serum level of Creatinine (Cr)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>kidney function(2)</measure>
      <time_frame>The outcome will be assessed at the 0,1,2,3,4 day after enrollment</time_frame>
      <description>serum level of blood urea nitrogen(BUN)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Indicators of infection</measure>
      <time_frame>The outcome will be assessed at the 0,1,2,3,4 day after enrollment</time_frame>
      <description>the serum level of procalcitonin(PCT)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The level of lactate</measure>
      <time_frame>The outcome will be assessed at the 0,1,2,3,4 day after enrollment</time_frame>
      <description>the serum level of lactic acid</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Duration of use of mechanical ventilation (MV)</measure>
      <time_frame>The outcome will be assessed at the 28 day after enrollment</time_frame>
      <description>The duration from the MV administration to the successful cessation in hours( The successful cessation is defined as the termination of MV for more than 48-hours. This outcome measure is intended only for patients receiving MV)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The duration of CRRT</measure>
      <time_frame>The outcome will be assessed at the 28 day after enrollment</time_frame>
      <description>The duration of CRRT therapy in hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Daily urine output</measure>
      <time_frame>The outcome will be assessed at the 1,2,3,4 day after enrollment</time_frame>
      <description>Daily urine output in milliliters from 0:00 - 24:00</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fluid balance</measure>
      <time_frame>The outcome will be assessed at the 1,2,3,4 day after enrollment</time_frame>
      <description>Net fluid intake and output in 24 hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The length of ICU stay</measure>
      <time_frame>The outcome will be assessed at the 28 day after enrollment</time_frame>
      <description>ICU length of ICU stay</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Incidence of adverse events</measure>
      <time_frame>The outcome will be assessed at the 28 day after enrollment</time_frame>
      <description>A adverse event refers to any adverse medical event that occur after the intervention of trial. The adverse events are not necessarily causally related to the trial treatment.</description>
    </other_outcome>
    <other_outcome>
      <measure>Incidence of serious adverse events</measure>
      <time_frame>The outcome will be assessed at the 28 day after enrollment</time_frame>
      <description>Any adverse medical event occurs at any dose that meets one or more of the following criteria: 1. causes death 2.life-threatening 3. requires hospitalization or hospitalization for an extended period of time 4. causes permanent or significant disability and functional defects 5. causes deformity.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Sepsis</condition>
    <condition>Septic Shock</condition>
    <arm_group>
      <arm_group_label>apigenin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>sterilized water</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Gastric tube injection of 5 ml of sterilized water for injection + conventional standardized treatment, for 4 consecutive days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>apigenin</intervention_name>
      <description>Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days.</description>
      <arm_group_label>apigenin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>sterilized water</intervention_name>
      <description>Intragastric tube injection of 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days.</description>
      <arm_group_label>sterilized water</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. age ≥65 years;&#xD;
  &#xD;
            2. meeting the diagnostic criteria of the 2016 International Sepsis Guidelines;&#xD;
  &#xD;
            3. subjects who voluntarily participated in this study and signed an informed consent&#xD;
               form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. patients who are allergic to the study products;&#xD;
  &#xD;
            2. patients who are unable to feed via gastrointestinal nutrition tube.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zhanguo Liu, M.D.PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Critical Care Medicine of Zhujiang Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zhanguo Liu, M.D.PhD</last_name>
      <phone>+862062782927</phone>
      <email>zhguoliu@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University</name>
        <address>
          <city>Guanzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zhanguo Liu, M.D.PhD</last_name>
        <phone>+862062782927</phone>
        <email>zhguoliu@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhujiang Hospital</investigator_affiliation>
      <investigator_full_name>Liu Zhanguo</investigator_full_name>
      <investigator_title>Director of the department of critical care medicine, Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>sepsis</keyword>
    <keyword>apigenin</keyword>
    <keyword>septic shock</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sepsis</mesh_term>
      <mesh_term>Toxemia</mesh_term>
      <mesh_term>Shock, Septic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>The datasets generated and analyzed during the study are available from the corresponding author on reasonable request.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999682
  org study id: 2023-KY-085-03
  nct id: NCT05999682
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  In this single-center, randomized, single-blind, placebo-controlled pilot clinical trial. The
        effect of apigenin on the improvement of organ function will be investigated in elderly
        patients with sepsis. Researchers will screen patients admitted to the Department of Critical
        Care Medicine at Zhujiang Hospital to identify patients with sepsis based on including and
        excluding criteria and obtain informed consent and randomize them into groups. The treatment
        group will be given apigenin tablets 50mg ground with 5ml of sterilized water for
        intra-gastric tube injection; the control group will be given an equal volume of sterilized
        water for intra-gastric tube injection. The changes in SOFA score and other clinically
        meaningful outcomes in 4 days will be collected.
  Investigational drug: Apigenin Study title: Improvement of Organ function by Apigenin in
        Elderly Patients With Sepsis: A Single-center, Single-blind, Randomized, Placebo-controlled,
        pilot Clinical Trial Principal Investigator: Zhanguo Liu, professor, Department of Critical
        Care Medicine, Zhujiang Hospital, Southern Medical University Study subjects: Elderly
        septic/septic shock patients who meet the diagnostic criteria of the 2016 International
        Sepsis Guidelines.
  
        Study objectives: The objective of the study is to determine whether apigenin, compared to
        placebo, improves organ dysfunction scores (SOFA scores) in elderly septic patients.
  
        Study design: A single-center, single-blind, randomized, placebo-controlled pilot Clinical
        Trial.
  
        Method: Apigenin group: Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml
        of sterilized water + conventional standardized treatment, for 4 days or until ICU discharge.
        Placebo control group: Gastric tube injection of 5 ml of sterilized water for injection +
        conventional standardized treatment, for 4 days or ICU discharge.
  
        Course: 4 days Sample size: 20 The number of study center: 1
  
        Study center:
  
          1. Department of Critical Care Medicine of Zhujiang Hospital, Guangzhou, Guangdong, China
             Primary endpoint: 96-hour Sequential Organ Failure Assessment (SOFA) score
  
             Secondary endpoints:
  
          2. The state of inflammatory response: the serum level of interleukin-6(IL-6) and
             C-reactive protein (CRP) at 96 h after randomization.
  
          3. The state of liver function: the serum level of transaminase (AST#ALT) #total bilirubin
             at 96 h after randomization.
  
          4. The state of lung function: oxygenation index (PaO2/FiO2) at 96h after Randomization.
  
          5. The state of kidney function: the serum level of Creatinine (Cr)#blood urea nitrogen
             (BUN)# at 96 h after randomization.
  
          6. The state of infection: the serum level of procalcitonin (PCT) at 96 h after
             randomization.
  
          7. The state of circulation system: the serum level of lactate at 96 h after Randomization.
  
          8. The duration of successful cessation of supportive therapies for organ dysfunction
             including vasoactive agents, mechanical ventilation.
  
          9. The daily urine output#duration of continuous renal replacement therapy (CRRT) #fluid
             balance.
  
         10. The length of stay in ICU.
  
        Safety endpoints:
  
          1. adverse events
  
          2. Serious adverse events
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Treatment group: Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 days or ICU discharge.
  Control group: Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 days or ICU discharge.
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Single(Participant)
  measure: 96-hour Sequential Organ Failure Assessment (SOFA) score
  time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
  description: The SOFA score is the Sequential Organ Failure Score, which is used to assess a patient's prognosis by determining the degree of impairment of major organ function. The score is divided into 6 sections: respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal, and ranges from 0 to 4, with higher SOFA scores associated with a higher incidence of poor prognosis.
  measure: inflammatory response(1)
  time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
  description: the serum level of C-reactive protein(CRP)
  measure: inflammatory response(2)
  time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
  description: the serum level of interleukin-6(IL-6)
  measure: Duration of use of vasoactive drugs
  time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
  description: The duration from the vasoactive drugs administration to the successful cessation in hours( The successful cessation is defined as the attainment of a clinician-prescribed mean arterial pressure target for more than 24-hours without the use of vasoactive drugs.This outcome measure is intended only for patients receiving vasoactive drugs)
  measure: liver function(1)
  time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
  description: the serum level of Alanine transaminase(ALT)
  measure: liver function(2)
  time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
  description: the serum level of Aspartate transaminase (AST)
  measure: liver function(3)
  time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
  description: the serum level of total bilirubin(TBil)
  measure: lung function
  time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
  description: oxygenation index(PaO2/FiO2),the patients treated with extracorporeal membrane oxygenation will not collect this indicator
  measure: kidney function(1)
  time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
  description: serum level of Creatinine (Cr)
  measure: kidney function(2)
  time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
  description: serum level of blood urea nitrogen(BUN)
  measure: Indicators of infection
  time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
  description: the serum level of procalcitonin(PCT)
  measure: The level of lactate
  time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
  description: the serum level of lactic acid
  measure: The Duration of use of mechanical ventilation (MV)
  time frame: The outcome will be assessed at the 28 day after enrollment
  description: The duration from the MV administration to the successful cessation in hours( The successful cessation is defined as the termination of MV for more than 48-hours. This outcome measure is intended only for patients receiving MV)
  measure: The duration of CRRT
  time frame: The outcome will be assessed at the 28 day after enrollment
  description: The duration of CRRT therapy in hours
  measure: Daily urine output
  time frame: The outcome will be assessed at the 1,2,3,4 day after enrollment
  description: Daily urine output in milliliters from 0:00 - 24:00
  measure: fluid balance
  time frame: The outcome will be assessed at the 1,2,3,4 day after enrollment
  description: Net fluid intake and output in 24 hours
  measure: The length of ICU stay
  time frame: The outcome will be assessed at the 28 day after enrollment
  description: ICU length of ICU stay
  measure: Incidence of adverse events
  time frame: The outcome will be assessed at the 28 day after enrollment
  description: A adverse event refers to any adverse medical event that occur after the intervention of trial. The adverse events are not necessarily causally related to the trial treatment.
  measure: Incidence of serious adverse events
  time frame: The outcome will be assessed at the 28 day after enrollment
  description: Any adverse medical event occurs at any dose that meets one or more of the following criteria: 1. causes death 2.life-threatening 3. requires hospitalization or hospitalization for an extended period of time 4. causes permanent or significant disability and functional defects 5. causes deformity.
  arm group label: apigenin
  arm group type: Experimental
  description: Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days.
  arm group label: sterilized water
  arm group type: Placebo Comparator
  description: Gastric tube injection of 5 ml of sterilized water for injection + conventional standardized treatment, for 4 consecutive days.
  intervention type: Other
  intervention name: apigenin
  description: Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days.
  arm group label: apigenin
  intervention type: Other
  intervention name: sterilized water
  description: Intragastric tube injection of 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days.
  arm group label: sterilized water
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Zhanguo Liu, M.D.PhD
  role: Principal Investigator
  affiliation: Department of Critical Care Medicine of Zhujiang Hospital
  last name: Zhanguo Liu, M.D.PhD
  phone: +862062782927
  email: zhguoliu@163.com
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Zhujiang Hospital
  investigator full name: Liu Zhanguo
  investigator title: Director of the department of critical care medicine, Principal Investigator
  mesh term: Sepsis
  mesh term: Toxemia
  mesh term: Shock, Septic
  sharing ipd: Undecided
  ipd description: The datasets generated and analyzed during the study are available from the corresponding author on reasonable request.