<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/NCT03267160</url>
  </required_header>
  <id_info>
    <org_study_id>05-XD15-039</org_study_id>
    <nct_id>NCT03267160</nct_id>
  </id_info>
  <brief_title>A Study of Exosome Proteomics and Hemodynamics in Sepsis</brief_title>
  <official_title>An Observation Study of Exosome Proteomics Released From Cardiopulmonary Organs and Hemodynamic Parameters in Sepsis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</source>
  <oversight_info>
    <has_dmc>No</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>
      This research will be the first study for exosomes purified in blood and urine from septic&#xD;
      patients who had multiple organ failures. Proteomics studies in exosomes from blood or urine&#xD;
      specimens. Analyze autophage, and apoptosis related biomarkers of exosomes by bioinformatics.&#xD;
      To find the correlations between exosomes biomarkers and hemodynamic parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Sepsis, defined as an infection with evidence of systemic infection, continues to&#xD;
      be a source of considerable morbidity and mortality. Many animal sepsis models had found that&#xD;
      sepsis induced multiple organ failure. Autophagy, apoptosis may involve the process of sepsis&#xD;
      related multiple organ failure. Mass spectrometry-based proteomics studies in clinical&#xD;
      populations and in rodent and mammalian animal models had started with discovered many novel&#xD;
      biomarkers of sepsis. Esoxomes had been found in blood or urine presented the signal of&#xD;
      autophagy and apoptosis. On the other hand, pulse contour cardiac output (PiCCO) can&#xD;
      calculate hemodynamic parameters that had been used for evaluation in cardiopulmonary failure&#xD;
      of sepsis.&#xD;
&#xD;
      Aims of the study: This research will be the first study for exosomes purified in blood and&#xD;
      urine from septic patients who had multiple organ failures. Proteomics studies in exosomes&#xD;
      from blood or urine specimens. Analyze autophage, and apoptosis related biomarkers of&#xD;
      exosomes by bioinformatics. To find the correlations between exosomes biomarkers and&#xD;
      hemodynamic parameters.&#xD;
&#xD;
      Materials and Methods: A total of 30 patients with sepsis, septic shock, or multiple organ&#xD;
      failure will be included, of whom 15 septic patients had cardiopulmonary organ failure,&#xD;
      others will be not. All patients included and classified according to the surviving sepsis&#xD;
      campaign criteria, also treat according to surviving sepsis campaign guidelines. Data will be&#xD;
      collected from January 2016 to December 2016. Exosome will be isolated and purified by&#xD;
      sucrose gradient ultracentrifugation. Magnetic beads purification, 2D gel electrphoresis, and&#xD;
      MALDI-TOF will be used to analyze proteomics of exosome in urine or blood of septic patients.&#xD;
      Western blotting will be done to prove the proteins found by proteomics. Pulse contour&#xD;
      cardiac output monitored heart contractility, end-diastolic volume parameters, and lung water&#xD;
      parameters. Finally, to find the correlations between exosome specific organ and&#xD;
      autophagy-apoptosis biomarkers and hemodynamic parameters.&#xD;
&#xD;
      Possible effect: Systematic establishment of exosome proteomics in blood and urine from&#xD;
      septic patients who had multiple organ failure or not will be done. Autophagy-apoptosis&#xD;
      biomarkers in exosomes will be detected and correlated to hemodynamic parameters, to judge&#xD;
      specific organ failure in sepsis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2020</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>Change of hemodynamic parameters (heart contractility: CFI)</measure>
    <time_frame>Baseline, 6 hours</time_frame>
    <description>Change from Baseline Cardiac function index (CFI; L/min) at 6 hours. Cardiac function index (CFI; L/min) will be calculated by thermodilution method. PiCCO2 device (Pulsion Medical Systems, Munich, Germany)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of hemodynamic parameters (preload: GEDI)</measure>
    <time_frame>Baseline, 6 hours</time_frame>
    <description>Change from Baseline Global end-diastolic index (GEDI; mL/m2) at 6 hours. Global end-diastolic index (GEDI; mL/m2) will be calculated by thermodilution method. PiCCO2 device (Pulsion Medical Systems, Munich, Germany).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of hemodynamic parameters (afterload: SVRI)</measure>
    <time_frame>Baseline, 6 hours</time_frame>
    <description>Change from Baseline Systemic vascular resistance index (SVRI; dynes x sec x cm-5/m2) at 6 hours. Systemic vascular resistance index (SVRI; dynes x sec x cm-5/m2) will be calculated by thermodilution method. PiCCO2 device (Pulsion Medical Systems, Munich, Germany).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of hemodynamic parameters (fluid responsiveness: SVV)</measure>
    <time_frame>Baseline, 6 hours, one day, and 3 days</time_frame>
    <description>Change from Baseline Stroke volume variation (SVV, %) at 6 hours. Stroke volume variation (SVV, %) will be calculated spontaneously by PiCCO2 device (Pulsion Medical Systems, Munich, Germany).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of hemodynamic parameters (lung water: ELWI)</measure>
    <time_frame>Baseline, 6 hours</time_frame>
    <description>Change from Baseline Extravascular lung water index (EVLWI; mL/kg) at 6 hours. Extravascular lung water index (EVLWI; mL/kg) will be calculated by the PiCCO device (Pulsion Medical Systems, Munich, Germany). EVLWI means total water in lung tissue, it increase in pulmonary edema or ARDS. PVPI means pulmonary vascular permeability and always high in ARDS (acute respiratory distress syndrome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of hemodynamic parameters (lung permeability: PVPI)</measure>
    <time_frame>Baseline, 6 hours</time_frame>
    <description>Change from Baseline pulmonary vascular permeability index (PVPI; ratio) at 6 hours. pulmonary vascular permeability index (PVPI) will be calculated by the PiCCO device (Pulsion Medical Systems, Munich, Germany). EVLWI means total water in lung tissue, it increase in pulmonary edema or ARDS. PVPI means pulmonary vascular permeability and always high in ARDS (acute respiratory distress syndrome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Autophagy biomarkers in exosomes: LC3II (Western blots)</measure>
    <time_frame>6 hours</time_frame>
    <description>LC3II appear during phagosome-lysomone fusion. Exosome will be collected from serum of sepsis. LC3II will be detected and identified by Western blots.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autophagy biomarkers in exosomes: LC3II (NTA)</measure>
    <time_frame>6 hours</time_frame>
    <description>LC3II appear during phagosome-lysomone fusion. Exosome will be collected from serum of sepsis. Later, LC3II will be marked and combined analysis by Nanoparticle tracing analysis. Concentrations (particles/mL) by size (nm) or Intensity (a.u.) by size (nm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autophagy modifiers in exosomes: mTOR (Western blots)</measure>
    <time_frame>6 hours</time_frame>
    <description>mammalian target of rapamycin (mTOR) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. mTOR will be detected and identified by Western blots.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autophagy modifiers in exosomes: mTOR (NTA)</measure>
    <time_frame>6 hours</time_frame>
    <description>mammalian target of rapamycin (mTOR) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. mTOR will be marked and combined analysis by Nanoparticle tracing analysis. Concentrations (particles/mL) by size (nm) or Intensity (a.u.) by size (nm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autophagy modifiers in exosomes: HSP70 (Western blots)</measure>
    <time_frame>6 hours</time_frame>
    <description>heat-shock protein 70 (HSP70) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. HSP70 will be detected and identified by Western blots.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autophagy modifiers in exosomes: HSP70 (NTA)</measure>
    <time_frame>6 hours</time_frame>
    <description>heat-shock protein 70 (HSP70) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. Later, HSP70 will be marked and combined analysis by Nanoparticle tracing analysis. Concentrations (particles/mL) by size (nm) or Intensity (a.u.) by size (nm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autophagy modifiers in exosomes: sequestosome 1 (Western blots)</measure>
    <time_frame>6 hours</time_frame>
    <description>sequestosome 1 (SQSMT1/p62) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. sequestosome 1 will be detected and identified by Western blots.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autophagy modifiers in exosomes: sequestosome 1 (NTA)</measure>
    <time_frame>6 hours</time_frame>
    <description>sequestosome 1 (SQSMT1/p62) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. Later, sequestosome 1 will be marked and combined analysis by Nanoparticle tracing analysis. Concentrations (particles/mL) by size (nm) or Intensity (a.u.) by size (nm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exosomes marker: CD9 (Western blots)</measure>
    <time_frame>6 hours</time_frame>
    <description>CD9 is the exosome surface marker. Exosome will be collected from serum of sepsis. CD9 will be detected and identified by Western blots.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exosomes marker: CD9 (NTA)</measure>
    <time_frame>6 hours</time_frame>
    <description>CD9 is the exosome surface marker. Exosome will be collected from serum of sepsis. Later, CD9 will be marked and combined analysis by Nanoparticle tracing analysis. Concentrations (particles/mL) by size (nm) or Intensity (a.u.) by size (nm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU mortality</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>ICU mortality (%), mortality during ICU admission/total ICU admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>28-day mortality</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>28-day mortality (%), mortality during 28-day/total 28-day admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality</measure>
    <time_frame>Up to 90 days</time_frame>
    <description>Hospital mortality (%), mortality during hospitalizaiton/total hospital admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in ICU</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Length of stay in ICU (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in hospital</measure>
    <time_frame>Up top 90 days</time_frame>
    <description>Length of stay in hospital (days)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Hemodynamic Instability</condition>
  <condition>Autophagy</condition>
  <arm_group>
    <arm_group_label>Sepsis with cardiopulmonary failure</arm_group_label>
    <description>Patient with sepsis and also respiratory and heart involvement, confirmed by Hemodynamic parameters</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sepsis without cardiopulmonary failure</arm_group_label>
    <description>Patient with sepsis without respiratory and heart involvement</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Hemodynamic parameters</intervention_name>
    <description>Pulse contour cardiac output monitored heart contractility, end-diastolic volume parameters, and lung water parameters.</description>
    <arm_group_label>Sepsis with cardiopulmonary failure</arm_group_label>
    <arm_group_label>Sepsis without cardiopulmonary failure</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and urine, extract exosome collection&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Sepsis was defined as a life-threatening organ dysfunction due to a dysregulated host&#xD;
        response to infection.&#xD;
&#xD;
        Patient with sepsis who was admitted to ICU. PiCCO hemodynamics was setted&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with sepsis who admit to ICU&#xD;
&#xD;
          2. Sepsis diagnostic criteria: acute change in total SOFA score ≥ 2 points attributable&#xD;
             to infection&#xD;
&#xD;
          3. Pulse indicator continuous cardiac output monitor (PiCCO) is accept by patient for&#xD;
             hemodynamic monitoring&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with acute SOFA changes &lt; 2 points are excluded&#xD;
&#xD;
          2. auria, no urine can be collected&#xD;
&#xD;
          3. Previous cardiopulmonary co-morbidity. Chronic respiratory failure with ventilator&#xD;
             dependence and chronic heart failure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wen-Lin Su, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Taipei Tzu Chi Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</name>
      <address>
        <city>Taipei</city>
        <zip>23142</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Lo S, Yuan SS, Hsu C, Cheng YJ, Chang YF, Hsueh HW, Lee PH, Hsieh YC. Lc3 over-expression improves survival and attenuates lung injury through increasing autophagosomal clearance in septic mice. Ann Surg. 2013 Feb;257(2):352-63. doi: 10.1097/SLA.0b013e318269d0e2.</citation>
    <PMID>22968077</PMID>
  </reference>
  <reference>
    <citation>Gao M, Ha T, Zhang X, Wang X, Liu L, Kalbfleisch J, Singh K, Williams D, Li C. The Toll-like receptor 9 ligand, CpG oligodeoxynucleotide, attenuates cardiac dysfunction in polymicrobial sepsis, involving activation of both phosphoinositide 3 kinase/Akt and extracellular-signal-related kinase signaling. J Infect Dis. 2013 May 1;207(9):1471-9. doi: 10.1093/infdis/jit036. Epub 2013 Jan 28.</citation>
    <PMID>23359590</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</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/NCT03267160
org study id: 05-XD15-039
nct id: NCT03267160
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research will be the first study for exosomes purified in blood and urine from septic
      patients who had multiple organ failures. Proteomics studies in exosomes from blood or urine
      specimens. Analyze autophage, and apoptosis related biomarkers of exosomes by bioinformatics.
      To find the correlations between exosomes biomarkers and hemodynamic parameters.
Background: Sepsis, defined as an infection with evidence of systemic infection, continues to
      be a source of considerable morbidity and mortality. Many animal sepsis models had found that
      sepsis induced multiple organ failure. Autophagy, apoptosis may involve the process of sepsis
      related multiple organ failure. Mass spectrometry-based proteomics studies in clinical
      populations and in rodent and mammalian animal models had started with discovered many novel
      biomarkers of sepsis. Esoxomes had been found in blood or urine presented the signal of
      autophagy and apoptosis. On the other hand, pulse contour cardiac output (PiCCO) can
      calculate hemodynamic parameters that had been used for evaluation in cardiopulmonary failure
      of sepsis.

      Aims of the study: This research will be the first study for exosomes purified in blood and
      urine from septic patients who had multiple organ failures. Proteomics studies in exosomes
      from blood or urine specimens. Analyze autophage, and apoptosis related biomarkers of
      exosomes by bioinformatics. To find the correlations between exosomes biomarkers and
      hemodynamic parameters.

      Materials and Methods: A total of 30 patients with sepsis, septic shock, or multiple organ
      failure will be included, of whom 15 septic patients had cardiopulmonary organ failure,
      others will be not. All patients included and classified according to the surviving sepsis
      campaign criteria, also treat according to surviving sepsis campaign guidelines. Data will be
      collected from January 2016 to December 2016. Exosome will be isolated and purified by
      sucrose gradient ultracentrifugation. Magnetic beads purification, 2D gel electrphoresis, and
      MALDI-TOF will be used to analyze proteomics of exosome in urine or blood of septic patients.
      Western blotting will be done to prove the proteins found by proteomics. Pulse contour
      cardiac output monitored heart contractility, end-diastolic volume parameters, and lung water
      parameters. Finally, to find the correlations between exosome specific organ and
      autophagy-apoptosis biomarkers and hemodynamic parameters.

      Possible effect: Systematic establishment of exosome proteomics in blood and urine from
      septic patients who had multiple organ failure or not will be done. Autophagy-apoptosis
      biomarkers in exosomes will be detected and correlated to hemodynamic parameters, to judge
      specific organ failure in sepsis.
observational model: Cohort
time perspective: Prospective
measure: Change of hemodynamic parameters (heart contractility: CFI)
time frame: Baseline, 6 hours
description: Change from Baseline Cardiac function index (CFI; L/min) at 6 hours. Cardiac function index (CFI; L/min) will be calculated by thermodilution method. PiCCO2 device (Pulsion Medical Systems, Munich, Germany)
measure: Change of hemodynamic parameters (preload: GEDI)
time frame: Baseline, 6 hours
description: Change from Baseline Global end-diastolic index (GEDI; mL/m2) at 6 hours. Global end-diastolic index (GEDI; mL/m2) will be calculated by thermodilution method. PiCCO2 device (Pulsion Medical Systems, Munich, Germany).
measure: Change of hemodynamic parameters (afterload: SVRI)
time frame: Baseline, 6 hours
description: Change from Baseline Systemic vascular resistance index (SVRI; dynes x sec x cm-5/m2) at 6 hours. Systemic vascular resistance index (SVRI; dynes x sec x cm-5/m2) will be calculated by thermodilution method. PiCCO2 device (Pulsion Medical Systems, Munich, Germany).
measure: Change of hemodynamic parameters (fluid responsiveness: SVV)
time frame: Baseline, 6 hours, one day, and 3 days
description: Change from Baseline Stroke volume variation (SVV, %) at 6 hours. Stroke volume variation (SVV, %) will be calculated spontaneously by PiCCO2 device (Pulsion Medical Systems, Munich, Germany).
measure: Change of hemodynamic parameters (lung water: ELWI)
time frame: Baseline, 6 hours
description: Change from Baseline Extravascular lung water index (EVLWI; mL/kg) at 6 hours. Extravascular lung water index (EVLWI; mL/kg) will be calculated by the PiCCO device (Pulsion Medical Systems, Munich, Germany). EVLWI means total water in lung tissue, it increase in pulmonary edema or ARDS. PVPI means pulmonary vascular permeability and always high in ARDS (acute respiratory distress syndrome)
measure: Change of hemodynamic parameters (lung permeability: PVPI)
time frame: Baseline, 6 hours
description: Change from Baseline pulmonary vascular permeability index (PVPI; ratio) at 6 hours. pulmonary vascular permeability index (PVPI) will be calculated by the PiCCO device (Pulsion Medical Systems, Munich, Germany). EVLWI means total water in lung tissue, it increase in pulmonary edema or ARDS. PVPI means pulmonary vascular permeability and always high in ARDS (acute respiratory distress syndrome)
measure: Autophagy biomarkers in exosomes: LC3II (Western blots)
time frame: 6 hours
description: LC3II appear during phagosome-lysomone fusion. Exosome will be collected from serum of sepsis. LC3II will be detected and identified by Western blots.
measure: Autophagy biomarkers in exosomes: LC3II (NTA)
time frame: 6 hours
description: LC3II appear during phagosome-lysomone fusion. Exosome will be collected from serum of sepsis. Later, LC3II will be marked and combined analysis by Nanoparticle tracing analysis. Concentrations (particles/mL) by size (nm) or Intensity (a.u.) by size (nm)
measure: Autophagy modifiers in exosomes: mTOR (Western blots)
time frame: 6 hours
description: mammalian target of rapamycin (mTOR) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. mTOR will be detected and identified by Western blots.
measure: Autophagy modifiers in exosomes: mTOR (NTA)
time frame: 6 hours
description: mammalian target of rapamycin (mTOR) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. mTOR will be marked and combined analysis by Nanoparticle tracing analysis. Concentrations (particles/mL) by size (nm) or Intensity (a.u.) by size (nm)
measure: Autophagy modifiers in exosomes: HSP70 (Western blots)
time frame: 6 hours
description: heat-shock protein 70 (HSP70) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. HSP70 will be detected and identified by Western blots.
measure: Autophagy modifiers in exosomes: HSP70 (NTA)
time frame: 6 hours
description: heat-shock protein 70 (HSP70) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. Later, HSP70 will be marked and combined analysis by Nanoparticle tracing analysis. Concentrations (particles/mL) by size (nm) or Intensity (a.u.) by size (nm)
measure: Autophagy modifiers in exosomes: sequestosome 1 (Western blots)
time frame: 6 hours
description: sequestosome 1 (SQSMT1/p62) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. sequestosome 1 will be detected and identified by Western blots.
measure: Autophagy modifiers in exosomes: sequestosome 1 (NTA)
time frame: 6 hours
description: sequestosome 1 (SQSMT1/p62) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. Later, sequestosome 1 will be marked and combined analysis by Nanoparticle tracing analysis. Concentrations (particles/mL) by size (nm) or Intensity (a.u.) by size (nm)
measure: Exosomes marker: CD9 (Western blots)
time frame: 6 hours
description: CD9 is the exosome surface marker. Exosome will be collected from serum of sepsis. CD9 will be detected and identified by Western blots.
measure: Exosomes marker: CD9 (NTA)
time frame: 6 hours
description: CD9 is the exosome surface marker. Exosome will be collected from serum of sepsis. Later, CD9 will be marked and combined analysis by Nanoparticle tracing analysis. Concentrations (particles/mL) by size (nm) or Intensity (a.u.) by size (nm)
measure: ICU mortality
time frame: Up to 30 days
description: ICU mortality (%), mortality during ICU admission/total ICU admission
measure: 28-day mortality
time frame: Up to 28 days
description: 28-day mortality (%), mortality during 28-day/total 28-day admission
measure: Hospital mortality
time frame: Up to 90 days
description: Hospital mortality (%), mortality during hospitalizaiton/total hospital admission
measure: Length of stay in ICU
time frame: Up to 30 days
description: Length of stay in ICU (days)
measure: Length of stay in hospital
time frame: Up top 90 days
description: Length of stay in hospital (days)
arm group label: Sepsis with cardiopulmonary failure
description: Patient with sepsis and also respiratory and heart involvement, confirmed by Hemodynamic parameters
arm group label: Sepsis without cardiopulmonary failure
description: Patient with sepsis without respiratory and heart involvement
intervention type: Diagnostic Test
intervention name: Hemodynamic parameters
description: Pulse contour cardiac output monitored heart contractility, end-diastolic volume parameters, and lung water parameters.
arm group label: Sepsis with cardiopulmonary failure
arm group label: Sepsis without cardiopulmonary failure
Blood and urine, extract exosome collection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 99 Years
healthy volunteers: No
last name: Wen-Lin Su, PhD
role: Study Director
affiliation: Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Taipei Tzu Chi Hospital
facility: 
country: Taiwan
citation: Lo S, Yuan SS, Hsu C, Cheng YJ, Chang YF, Hsueh HW, Lee PH, Hsieh YC. Lc3 over-expression improves survival and attenuates lung injury through increasing autophagosomal clearance in septic mice. Ann Surg. 2013 Feb;257(2):352-63. doi: 10.1097/SLA.0b013e318269d0e2.
PMID: 22968077
citation: Gao M, Ha T, Zhang X, Wang X, Liu L, Kalbfleisch J, Singh K, Williams D, Li C. The Toll-like receptor 9 ligand, CpG oligodeoxynucleotide, attenuates cardiac dysfunction in polymicrobial sepsis, involving activation of both phosphoinositide 3 kinase/Akt and extracellular-signal-related kinase signaling. J Infect Dis. 2013 May 1;207(9):1471-9. doi: 10.1093/infdis/jit036. Epub 2013 Jan 28.
PMID: 23359590
responsible party type: Sponsor
mesh term: Sepsis