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/NCT06006325</url>
    </required_header>
    <id_info>
      <org_study_id>NKYY_YXKT_IRB_2022_023_01</org_study_id>
      <nct_id>NCT06006325</nct_id>
    </id_info>
    <brief_title>Electroacupuncture Modulates SPMs Metabolism and Respiratory Symptoms in Patients With Sepsis Complicating ARDS</brief_title>
    <official_title>Electroacupuncture Modulates the Metabolism of SPMs and Ameliorates Respiratory Symptoms and Inflammation in Patients With Sepsis Complicating ARDS</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tianjin Nankai Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tianjin Nankai Hospital</source>
    <oversight_info>
      <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 interventional clinical trial, researchers will administer electroacupuncture versus&#xD;
        sham electroacupuncture to sepsis patients with ARDS and collect objective outcome measures.&#xD;
        The study will be divided into 2 groups. The EA group will receive electroacupuncture and the&#xD;
        SHAM-EA group will receive sham electroacupuncture. The purpose of this study is to&#xD;
        investigate the effect of electroacupuncture on the synthesis of SPMs in sepsis patients with&#xD;
        ARDS.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 20, 2023</start_date>
    <completion_date type="Anticipated">March 2, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Serum levels of Lipoxin A4 (LXA4)</measure>
      <time_frame>Up to 7 days</time_frame>
      <description>Serum levels of LXA4 were measured in post-intervention patients and levels were compared to Day 0.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>LXA4 levels in BALF</measure>
      <time_frame>Up to 7 days</time_frame>
      <description>LXA4 levels were measured in the BALF of patients after the intervention and the levels were compared to day 0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ventilation-free days</measure>
      <time_frame>Up to 28 days</time_frame>
      <description>The number of days the patient was alive and free of mechanical ventilation (MV)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oxygenation index</measure>
      <time_frame>Up to 7 days</time_frame>
      <description>The ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ventilator-provided positive end-expiratory pressure (PEEP)</measure>
      <time_frame>Up to 7 days</time_frame>
      <description>Ventilator parameter</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>plateau pressure</measure>
      <time_frame>Up to 7 days</time_frame>
      <description>Ventilator parameter</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>tidal volume</measure>
      <time_frame>Up to 7 days</time_frame>
      <description>Ventilator parameter</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inflammation biomarkers Inflammation levels</measure>
      <time_frame>Up to 7 days</time_frame>
      <description>Procalcitonin (PCT), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sequential Organ-Failure Assessment (SOFA) score</measure>
      <time_frame>Up to 7 days</time_frame>
      <description>The SOFA score is used to assess the severity and prognosis of sepsis.SOFA was based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of electroacupuncture-related adverse events</measure>
      <time_frame>Up to 28 days</time_frame>
      <description>Rate of electroacupuncture-related adverse events</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Sepsis</condition>
    <condition>Acute Respiratory Distress Syndrome</condition>
    <arm_group>
      <arm_group_label>Electroacupuncture (EA)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The acupoints were &quot;Deqi&quot;, and the electroacupuncture stimulator was connected and energized.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham electroacupuncture (SHAM-EA)</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>No &quot;Deqi&quot; operation was performed on non-acupuncture points, and the electroacupuncture stimulator was connected and not energized.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>electroacupuncture treatment</intervention_name>
      <description>Patients received acupuncture on both sides of the Zusanli (ST36) acupuncture points, and after &quot;Deqi &quot;, the needle was connected to an electro-acupuncture device (Hwato, Suzhou Medical ). The EA stimulation lasted for 30 min.</description>
      <arm_group_label>Electroacupuncture (EA)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>sham electroacupuncture treatment</intervention_name>
      <description>The participants in the SHAM-EA group performed shallow punctures at the bilateral non-acupuncture points, did not perform the &quot;Deqi&quot; operation, and were connected to the electroacupuncture stimulator but not energized.</description>
      <arm_group_label>Sham electroacupuncture (SHAM-EA)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Males or females over the age of 18;&#xD;
  &#xD;
            2. Diagnosis meets SPESIS 3 criteria for sepsis;&#xD;
  &#xD;
            3. The diagnosis meets the Berlin diagnostic criteria for ARDS;&#xD;
  &#xD;
            4. ARDS was diagnosed within 48h;&#xD;
  &#xD;
            5. Capable of understanding the purpose and risk of the study;&#xD;
  &#xD;
            6. Patients or proxy must give written informed consent before any assessment is&#xD;
               performed.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. ARDS was diagnosed 48h later;&#xD;
  &#xD;
            2. Pregnancy, lactation or perinatal period;&#xD;
  &#xD;
            3. malignant tumor;&#xD;
  &#xD;
            4. Severe liver failure or kidney failure;&#xD;
  &#xD;
            5. Predicted mortality risk of patients within 24h&gt;80%;&#xD;
  &#xD;
            6. Severe end-stage lung disease;&#xD;
  &#xD;
            7. ECMO patients are undergoing implementation;&#xD;
  &#xD;
            8. HIV seropositive or Syphilis seropositive;&#xD;
  &#xD;
            9. Any clinical-relevant condition that might affect study participation and/or study&#xD;
               results;&#xD;
  &#xD;
           10. Participation in any other intervention trial;&#xD;
  &#xD;
           11. Unwillingness or inability to following the study protocol in the investigators&#xD;
               opinion.&#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_official>
      <last_name>Jianbo Yu, MD</last_name>
      <role>Study Director</role>
      <affiliation>Tianjin Nankai Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jianbo Yu, MD</last_name>
      <phone>+8615344422323</phone>
      <email>30717008@nankai.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tianjin Nankai Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shuan Dong, Professor</last_name>
        <phone>（022）27435008</phone>
        <phone_ext>（022）27435027</phone_ext>
        <email>dongshuan@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Liu S, Wang Z, Su Y, Qi L, Yang W, Fu M, Jing X, Wang Y, Ma Q. A neuroanatomical basis for electroacupuncture to drive the vagal-adrenal axis. Nature. 2021 Oct;598(7882):641-645. doi: 10.1038/s41586-021-04001-4. Epub 2021 Oct 13. Erratum In: Nature. 2022 Jan;601(7893):E9.</citation>
      <PMID>34646018</PMID>
    </reference>
    <reference>
      <citation>Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.</citation>
      <PMID>23480440</PMID>
    </reference>
    <reference>
      <citation>Cecconi M, Evans L, Levy M, Rhodes A. Sepsis and septic shock. Lancet. 2018 Jul 7;392(10141):75-87. doi: 10.1016/S0140-6736(18)30696-2. Epub 2018 Jun 21.</citation>
      <PMID>29937192</PMID>
    </reference>
    <reference>
      <citation>Fowler AA 3rd, Truwit JD, Hite RD, Morris PE, DeWilde C, Priday A, Fisher B, Thacker LR 2nd, Natarajan R, Brophy DF, Sculthorpe R, Nanchal R, Syed A, Sturgill J, Martin GS, Sevransky J, Kashiouris M, Hamman S, Egan KF, Hastings A, Spencer W, Tench S, Mehkri O, Bindas J, Duggal A, Graf J, Zellner S, Yanny L, McPolin C, Hollrith T, Kramer D, Ojielo C, Damm T, Cassity E, Wieliczko A, Halquist M. Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial. JAMA. 2019 Oct 1;322(13):1261-1270. doi: 10.1001/jama.2019.11825. Erratum In: JAMA. 2020 Jan 28;323(4):379.</citation>
      <PMID>31573637</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tianjin Nankai Hospital</investigator_affiliation>
      <investigator_full_name>Jianbo Yu</investigator_full_name>
      <investigator_title>Prof.</investigator_title>
    </responsible_party>
    <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>Respiratory Distress Syndrome</mesh_term>
      <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
      <mesh_term>Acute Lung Injury</mesh_term>
      <mesh_term>Signs and Symptoms, Respiratory</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06006325
  org study id: NKYY_YXKT_IRB_2022_023_01
  nct id: NCT06006325
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In this interventional clinical trial, researchers will administer electroacupuncture versus
        sham electroacupuncture to sepsis patients with ARDS and collect objective outcome measures.
        The study will be divided into 2 groups. The EA group will receive electroacupuncture and the
        SHAM-EA group will receive sham electroacupuncture. The purpose of this study is to
        investigate the effect of electroacupuncture on the synthesis of SPMs in sepsis patients with
        ARDS.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Care Provider)
  measure: Serum levels of Lipoxin A4 (LXA4)
  time frame: Up to 7 days
  description: Serum levels of LXA4 were measured in post-intervention patients and levels were compared to Day 0.
  measure: LXA4 levels in BALF
  time frame: Up to 7 days
  description: LXA4 levels were measured in the BALF of patients after the intervention and the levels were compared to day 0.
  measure: Ventilation-free days
  time frame: Up to 28 days
  description: The number of days the patient was alive and free of mechanical ventilation (MV)
  measure: Oxygenation index
  time frame: Up to 7 days
  description: The ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage).
  measure: Ventilator-provided positive end-expiratory pressure (PEEP)
  time frame: Up to 7 days
  description: Ventilator parameter
  measure: plateau pressure
  time frame: Up to 7 days
  description: Ventilator parameter
  measure: tidal volume
  time frame: Up to 7 days
  description: Ventilator parameter
  measure: Inflammation biomarkers Inflammation levels
  time frame: Up to 7 days
  description: Procalcitonin (PCT), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6)
  measure: Sequential Organ-Failure Assessment (SOFA) score
  time frame: Up to 7 days
  description: The SOFA score is used to assess the severity and prognosis of sepsis.SOFA was based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction.
  measure: Rate of electroacupuncture-related adverse events
  time frame: Up to 28 days
  description: Rate of electroacupuncture-related adverse events
  arm group label: Electroacupuncture (EA)
  arm group type: Experimental
  description: The acupoints were "Deqi", and the electroacupuncture stimulator was connected and energized.
  arm group label: Sham electroacupuncture (SHAM-EA)
  arm group type: Sham Comparator
  description: No "Deqi" operation was performed on non-acupuncture points, and the electroacupuncture stimulator was connected and not energized.
  intervention type: Device
  intervention name: electroacupuncture treatment
  description: Patients received acupuncture on both sides of the Zusanli (ST36) acupuncture points, and after "Deqi ", the needle was connected to an electro-acupuncture device (Hwato, Suzhou Medical ). The EA stimulation lasted for 30 min.
  arm group label: Electroacupuncture (EA)
  intervention type: Device
  intervention name: sham electroacupuncture treatment
  description: The participants in the SHAM-EA group performed shallow punctures at the bilateral non-acupuncture points, did not perform the "Deqi" operation, and were connected to the electroacupuncture stimulator but not energized.
  arm group label: Sham electroacupuncture (SHAM-EA)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jianbo Yu, MD
  role: Study Director
  affiliation: Tianjin Nankai Hospital
  last name: Jianbo Yu, MD
  phone: +8615344422323
  email: 30717008@nankai.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: Liu S, Wang Z, Su Y, Qi L, Yang W, Fu M, Jing X, Wang Y, Ma Q. A neuroanatomical basis for electroacupuncture to drive the vagal-adrenal axis. Nature. 2021 Oct;598(7882):641-645. doi: 10.1038/s41586-021-04001-4. Epub 2021 Oct 13. Erratum In: Nature. 2022 Jan;601(7893):E9.
  PMID: 34646018
  citation: Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
  PMID: 23480440
  citation: Cecconi M, Evans L, Levy M, Rhodes A. Sepsis and septic shock. Lancet. 2018 Jul 7;392(10141):75-87. doi: 10.1016/S0140-6736(18)30696-2. Epub 2018 Jun 21.
  PMID: 29937192
  citation: Fowler AA 3rd, Truwit JD, Hite RD, Morris PE, DeWilde C, Priday A, Fisher B, Thacker LR 2nd, Natarajan R, Brophy DF, Sculthorpe R, Nanchal R, Syed A, Sturgill J, Martin GS, Sevransky J, Kashiouris M, Hamman S, Egan KF, Hastings A, Spencer W, Tench S, Mehkri O, Bindas J, Duggal A, Graf J, Zellner S, Yanny L, McPolin C, Hollrith T, Kramer D, Ojielo C, Damm T, Cassity E, Wieliczko A, Halquist M. Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial. JAMA. 2019 Oct 1;322(13):1261-1270. doi: 10.1001/jama.2019.11825. Erratum In: JAMA. 2020 Jan 28;323(4):379.
  PMID: 31573637
  responsible party type: Principal Investigator
  investigator affiliation: Tianjin Nankai Hospital
  investigator full name: Jianbo Yu
  investigator title: Prof.
  mesh term: Sepsis
  mesh term: Toxemia
  mesh term: Respiratory Distress Syndrome
  mesh term: Respiratory Distress Syndrome, Newborn
  mesh term: Acute Lung Injury
  mesh term: Signs and Symptoms, Respiratory
  sharing ipd: No