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/NCT05968287</url>
    </required_header>
    <id_info>
      <org_study_id>GaziUtipNBDundar002</org_study_id>
      <nct_id>NCT05968287</nct_id>
    </id_info>
    <brief_title>Can Measurement of Neutrophil-derived ROS Production be a Novel Biomarker of Sepsis?</brief_title>
    <acronym>LIT-sepsis</acronym>
    <official_title>Evaluation of the Relationship of Neutrophil Functions With Sepsis and Septic Shock Using the Leukocyte ImmunoTest™ in Patients With Various Infectious Conditions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gazi University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Seroxo Ltd</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Gazi University</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>
        Neutrophils are indispensable for host defense and have an important roles in modulating the&#xD;
        immune system in both the innate and adaptive immune response. Neutrophils operate using a&#xD;
        number of different mechanisms including chemotaxis, phagocytosis, release of reactive oxygen&#xD;
        species (ROS) and granular proteins, and the production and liberation of cytokines for this&#xD;
        purpose. A controlled neutrophil response is required to combat infection; an dysregulated&#xD;
        state of this response can cause sepsis, tissue damage, and organ failure. Sepsis and septic&#xD;
        shock are the leading causes of death especially in intensive care units (ICU), and their&#xD;
        mortality can be reduced with prompt diagnosis and appropriate treatment modality. From this&#xD;
        point of view, many biomarkers have been evaluated for the diagnosis, prognosis, and&#xD;
        treatment response of infection and sepsis. An objective marker of cellular dysfunction of&#xD;
        neutrophils would be a helpful tool for the clinician in detecting and monitoring changes&#xD;
        related to infection status and to determine development of sepsis and positive effects of&#xD;
        interventions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction:&#xD;
  &#xD;
        Sepsis is defined as the dysregulated host response to infection leading to organ&#xD;
        dysfunction. Both sepsis and septic shock are important health problems affecting millions of&#xD;
        people, resulting in a serious mortality rate around the world every year. Delay in both&#xD;
        diagnosis and initiation of appropriate treatment are the most important causes of&#xD;
        sepsis-related mortality. On the other hand, overdiagnosis of sepsis and initiation of&#xD;
        broad-spectrum antibiotic therapy inappropriately have some consequences such as increased&#xD;
        hospital costs, antibiotic-related side effects, increased antibiotic resistance, and the&#xD;
        development of resistant nosocomial infections. To make this precise distinction, a large&#xD;
        number of biomarkers have been studied until today. The expected benefit of sepsis-related&#xD;
        biomarkers is the detection of infection and sepsis, the potential to predict the course of&#xD;
        sepsis, or treatment guidance. Although there are more than 150 biomarkers studied on this&#xD;
        subject, there is not a single biomarker that meets these expectations in all aspects in&#xD;
        clinical practice.&#xD;
  &#xD;
        Neutrophils play a vital role in the development of the host response in sepsis. Neutrophils&#xD;
        operate using a number of different mechanisms including chemotaxis, phagocytosis, release of&#xD;
        reactive oxygen species (ROS) and granular proteins, and the production and liberation of&#xD;
        cytokines for this purpose. A controlled neutrophil response is required to combat&#xD;
        infections. Recently a functional assay that assesses the capacity of leukocytes (primarily&#xD;
        neutrophils) to produce ROS in response to in vitro chemical stimulation has been&#xD;
        demonstrated. The Leukocyte ImmunoTest™ (LIT™) specifically and rapidly (10 minutes)&#xD;
        quantifies neutrophil ROS release using a small volume of blood obtainable from capillary,&#xD;
        arterial or venous sources. As such the LIT score provides a physiologically relevant means&#xD;
        for monitoring the cellular capacity of neutrophils to produce superoxide radicals in real&#xD;
        time. An objective marker of cellular dysfunction of neutrophils would be a helpful tool for&#xD;
        the clinician in detecting and monitoring changes related to infection status and to&#xD;
        determine development of sepsis and positive effects of interventions.&#xD;
  &#xD;
        Method:&#xD;
  &#xD;
        The study was conducted as a prospective observational study with ethical committee approval&#xD;
        in a medical intensive care unit and inward belong to internal disease department of a&#xD;
        university hospital. The patient population is consisted of patients who were admitted to the&#xD;
        ICU or inward due various infectious etiologies. The control group is consisted of&#xD;
        outpatients or inpatients admitted to ICU or inward for noninfectious etiologies. ROS&#xD;
        production in response to PMA was performed on clinical samples and analysed within 30&#xD;
        minutes of collection. The LIT test was performed every day or every other day for patient&#xD;
        group until death or discharge from units where the study is conducted. The LIT test was&#xD;
        performed only once for outpatient group on day of outpatient control.&#xD;
  &#xD;
        Measurements of ROS production by luminometer:&#xD;
  &#xD;
        ROS production was measured on clinical samples taken for routine testing. Briefly, 10μl&#xD;
        samples of freshly obtained blood (obtained by venepuncture) was added to 100 microlitres&#xD;
        phosphate buffered saline (PBS) containing phorbol 12-myristate 13-acetate (PMA; Sigma) and&#xD;
        luminol. The solution was incubated for 10 minutes at 37.5 °C. Chemiluminescence was&#xD;
        quantified after 10 minutes using handheld luminometer (3M, Clean-Trace, NG3) in relative&#xD;
        light units (RLU). LIT scores as a correlate of neutrophil function for each patient were&#xD;
        plotted. Abnormally high (hyperproduction) ROS generation was associated with infection,&#xD;
        sepsis or septic shock. This raises the possibility of LIT™ and LIT™/neutrophil-count ratio,&#xD;
        (LIT/N), being used as a predictive clinical tool.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 28, 2022</start_date>
    <completion_date type="Actual">January 31, 2023</completion_date>
    <primary_completion_date type="Actual">January 27, 2023</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>the reactive oxygen species (ROS) production of neutrophils via the Leukocyte ImmunoTest™ (LIT)</measure>
      <time_frame>Patients' LIT scores in relative light units (RLU) within 24 hours following the day of hospitalization during the study period</time_frame>
      <description>the difference of the Leukocyte ImmunoTest™ (LIT) as relative light unit (RLU) between patients with various infection conditions and control groups without infection.&#xD;
  Abnormally high (hyperproduction) ROS generation demonstrated via The Leukocyte ImmunoTest™ (LIT) is associated with infection. LIT scores as relative light unit (RLU) can vary between 1-15000.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>the reactive oxygen species (ROS) production of neutrophils via the Leukocyte ImmunoTest™ (LIT)</measure>
      <time_frame>LIT score as as relative light unit (RLU) of the day of detecting of infection and sepsis up to 8 months</time_frame>
      <description>the difference of the Leukocyte ImmunoTest™ (LIT) as relative light unit (RLU) between patients between sepsis and without sepsis&#xD;
  Abnormally high (hyperproduction) ROS generation demonstrated via The Leukocyte ImmunoTest™ (LIT) is associated with sepsis and septic shock. LIT scores as relative light unit (RLU) can vary between 1-15000.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>the reactive oxygen species (ROS) production of neutrophils via the Leukocyte ImmunoTest™ (LIT)</measure>
      <time_frame>the Leukocyte ImmunoTest™ (LIT) as relative light unit (RLU) of the patients with sepsis on every day or every other day up to death or discharge from the hospital through the study completion, an average of 8 months</time_frame>
      <description>the difference of the Leukocyte ImmunoTest™ (LIT) as relative light unit (RLU) between survivors and nonsurvivors within the septic patients.&#xD;
  Abnormally high (hyperproduction) ROS generation demonstrated via The Leukocyte ImmunoTest™ (LIT) is associated with infection, sepsis and septic shock. LIT scores as relative light unit (RLU) can vary between 1-15000. The relationship of high scores of the LIT as relative light unit (RLU) with mortality will be evaluated.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">276</enrollment>
    <condition>Infections</condition>
    <condition>Sepsis</condition>
    <condition>Septic Shock</condition>
    <arm_group>
      <arm_group_label>patient group</arm_group_label>
      <description>patients admitted to hospital with various infection conditions with or without sepsis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <description>patients admitted to hospital with various non-infectious diseases and outpatients who admitted to the outpatient clinics</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>The Leukocyte ImmunoTest™ (LIT™)</intervention_name>
      <description>The baseline LIT scores was performed for two parallel groups. The sequential LIT score was also performed for patients with various infection conditions with/without sepsis.</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>patient group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The patient population is consisted of patients who were admitted to the ICU or inward due&#xD;
          various infectious etiologies. The control population is consisted of outpatients or&#xD;
          inpatients admitted to ICU or inward for noninfectious etiologies.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Diagnosis or suspicion of various infectious disease with or without sepsis and&#xD;
               admitted to the ICU or inpatient service due to this clinical diagnosis for patient&#xD;
               group&#xD;
  &#xD;
            2. Patients followed in the inpatient service due to various non-infectious diseases and&#xD;
               outpatients who were examined in outpatient clinics for control group&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. patient or control group under the age of 18 years&#xD;
  &#xD;
            2. Patients died within the 24 hours after hospital admission&#xD;
  &#xD;
            3. Patients who did not sign informed consent&#xD;
  &#xD;
            4. Refusal of legal representative to participate in the study in unconscious patients&#xD;
  &#xD;
            5. Patients with an absolute neutrophil count &lt;500/mm3 on admission&#xD;
  &#xD;
            6. Control group describing any infective symptoms&#xD;
  &#xD;
            7. Control group with a chronic infectious disease under treatment&#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>Nazlıhan Boyacı Dündar, assist.prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>principle investigator</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Gazi University</name>
        <address>
          <city>Ankara</city>
          <state>Yenimahalle</state>
          <zip>06560</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Mortaz E, Alipoor SD, Adcock IM, Mumby S, Koenderman L. Update on Neutrophil Function in Severe Inflammation. Front Immunol. 2018 Oct 2;9:2171. doi: 10.3389/fimmu.2018.02171. eCollection 2018.</citation>
      <PMID>30356867</PMID>
    </reference>
    <reference>
      <citation>Selders GS, Fetz AE, Radic MZ, Bowlin GL. An overview of the role of neutrophils in innate immunity, inflammation and host-biomaterial integration. Regen Biomater. 2017 Feb;4(1):55-68. doi: 10.1093/rb/rbw041.</citation>
      <PMID>28149530</PMID>
    </reference>
    <reference>
      <citation>Hellebrekers P, Vrisekoop N, Koenderman L. Neutrophil phenotypes in health and disease. Eur J Clin Invest. 2018 Nov;48 Suppl 2(Suppl Suppl 2):e12943. doi: 10.1111/eci.12943. Epub 2018 May 25.</citation>
      <PMID>29682724</PMID>
    </reference>
    <reference>
      <citation>Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.</citation>
      <PMID>34599691</PMID>
    </reference>
    <reference>
      <citation>Ferrer R, Martin-Loeches I, Phillips G, Osborn TM, Townsend S, Dellinger RP, Artigas A, Schorr C, Levy MM. Empiric antibiotic treatment reduces mortality in severe sepsis and septic shock from the first hour: results from a guideline-based performance improvement program. Crit Care Med. 2014 Aug;42(8):1749-55. doi: 10.1097/CCM.0000000000000330.</citation>
      <PMID>24717459</PMID>
    </reference>
    <reference>
      <citation>Pierrakos C, Velissaris D, Bisdorff M, Marshall JC, Vincent JL. Biomarkers of sepsis: time for a reappraisal. Crit Care. 2020 Jun 5;24(1):287. doi: 10.1186/s13054-020-02993-5.</citation>
      <PMID>32503670</PMID>
    </reference>
    <reference>
      <citation>Fleischmann-Struzek C, Mellhammar L, Rose N, Cassini A, Rudd KE, Schlattmann P, Allegranzi B, Reinhart K. Incidence and mortality of hospital- and ICU-treated sepsis: results from an updated and expanded systematic review and meta-analysis. Intensive Care Med. 2020 Aug;46(8):1552-1562. doi: 10.1007/s00134-020-06151-x. Epub 2020 Jun 22.</citation>
      <PMID>32572531</PMID>
    </reference>
    <reference>
      <citation>Rhee C, Chiotos K, Cosgrove SE, Heil EL, Kadri SS, Kalil AC, Gilbert DN, Masur H, Septimus EJ, Sweeney DA, Strich JR, Winslow DL, Klompas M. Infectious Diseases Society of America Position Paper: Recommended Revisions to the National Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) Sepsis Quality Measure. Clin Infect Dis. 2021 Feb 16;72(4):541-552. doi: 10.1093/cid/ciaa059.</citation>
      <PMID>32374861</PMID>
    </reference>
    <reference>
      <citation>Biomarkers Definitions Working Group.. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001 Mar;69(3):89-95. doi: 10.1067/mcp.2001.113989. No abstract available.</citation>
      <PMID>11240971</PMID>
    </reference>
    <reference>
      <citation>Veenith T, Martin H, Le Breuilly M, Whitehouse T, Gao-Smith F, Duggal N, Lord JM, Mian R, Sarphie D, Moss P. High generation of reactive oxygen species from neutrophils in patients with severe COVID-19. Sci Rep. 2022 Jun 21;12(1):10484. doi: 10.1038/s41598-022-13825-7.</citation>
      <PMID>35729319</PMID>
    </reference>
    <reference>
      <citation>Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.</citation>
      <PMID>26903338</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 4, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Gazi University</investigator_affiliation>
      <investigator_full_name>Nazlıhan Boyacı Dündar</investigator_full_name>
      <investigator_title>assistan professor, Division of Intensive Care Medicine (principle invastigator)</investigator_title>
    </responsible_party>
    <keyword>cellular dysfunction of neutrophils</keyword>
    <keyword>reactive oxygen species (ROS)</keyword>
    <keyword>sepsis</keyword>
    <keyword>septic shock</keyword>
    <keyword>infections</keyword>
    <keyword>biomarker</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>
      <mesh_term>Shock</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/NCT05968287
  org study id: GaziUtipNBDundar002
  nct id: NCT05968287
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Neutrophils are indispensable for host defense and have an important roles in modulating the
        immune system in both the innate and adaptive immune response. Neutrophils operate using a
        number of different mechanisms including chemotaxis, phagocytosis, release of reactive oxygen
        species (ROS) and granular proteins, and the production and liberation of cytokines for this
        purpose. A controlled neutrophil response is required to combat infection; an dysregulated
        state of this response can cause sepsis, tissue damage, and organ failure. Sepsis and septic
        shock are the leading causes of death especially in intensive care units (ICU), and their
        mortality can be reduced with prompt diagnosis and appropriate treatment modality. From this
        point of view, many biomarkers have been evaluated for the diagnosis, prognosis, and
        treatment response of infection and sepsis. An objective marker of cellular dysfunction of
        neutrophils would be a helpful tool for the clinician in detecting and monitoring changes
        related to infection status and to determine development of sepsis and positive effects of
        interventions.
  Introduction:
  
        Sepsis is defined as the dysregulated host response to infection leading to organ
        dysfunction. Both sepsis and septic shock are important health problems affecting millions of
        people, resulting in a serious mortality rate around the world every year. Delay in both
        diagnosis and initiation of appropriate treatment are the most important causes of
        sepsis-related mortality. On the other hand, overdiagnosis of sepsis and initiation of
        broad-spectrum antibiotic therapy inappropriately have some consequences such as increased
        hospital costs, antibiotic-related side effects, increased antibiotic resistance, and the
        development of resistant nosocomial infections. To make this precise distinction, a large
        number of biomarkers have been studied until today. The expected benefit of sepsis-related
        biomarkers is the detection of infection and sepsis, the potential to predict the course of
        sepsis, or treatment guidance. Although there are more than 150 biomarkers studied on this
        subject, there is not a single biomarker that meets these expectations in all aspects in
        clinical practice.
  
        Neutrophils play a vital role in the development of the host response in sepsis. Neutrophils
        operate using a number of different mechanisms including chemotaxis, phagocytosis, release of
        reactive oxygen species (ROS) and granular proteins, and the production and liberation of
        cytokines for this purpose. A controlled neutrophil response is required to combat
        infections. Recently a functional assay that assesses the capacity of leukocytes (primarily
        neutrophils) to produce ROS in response to in vitro chemical stimulation has been
        demonstrated. The Leukocyte ImmunoTest™ (LIT™) specifically and rapidly (10 minutes)
        quantifies neutrophil ROS release using a small volume of blood obtainable from capillary,
        arterial or venous sources. As such the LIT score provides a physiologically relevant means
        for monitoring the cellular capacity of neutrophils to produce superoxide radicals in real
        time. An objective marker of cellular dysfunction of neutrophils would be a helpful tool for
        the clinician in detecting and monitoring changes related to infection status and to
        determine development of sepsis and positive effects of interventions.
  
        Method:
  
        The study was conducted as a prospective observational study with ethical committee approval
        in a medical intensive care unit and inward belong to internal disease department of a
        university hospital. The patient population is consisted of patients who were admitted to the
        ICU or inward due various infectious etiologies. The control group is consisted of
        outpatients or inpatients admitted to ICU or inward for noninfectious etiologies. ROS
        production in response to PMA was performed on clinical samples and analysed within 30
        minutes of collection. The LIT test was performed every day or every other day for patient
        group until death or discharge from units where the study is conducted. The LIT test was
        performed only once for outpatient group on day of outpatient control.
  
        Measurements of ROS production by luminometer:
  
        ROS production was measured on clinical samples taken for routine testing. Briefly, 10μl
        samples of freshly obtained blood (obtained by venepuncture) was added to 100 microlitres
        phosphate buffered saline (PBS) containing phorbol 12-myristate 13-acetate (PMA; Sigma) and
        luminol. The solution was incubated for 10 minutes at 37.5 °C. Chemiluminescence was
        quantified after 10 minutes using handheld luminometer (3M, Clean-Trace, NG3) in relative
        light units (RLU). LIT scores as a correlate of neutrophil function for each patient were
        plotted. Abnormally high (hyperproduction) ROS generation was associated with infection,
        sepsis or septic shock. This raises the possibility of LIT™ and LIT™/neutrophil-count ratio,
        (LIT/N), being used as a predictive clinical tool.
  observational model: Cohort
  time perspective: Prospective
  measure: the reactive oxygen species (ROS) production of neutrophils via the Leukocyte ImmunoTest™ (LIT)
  time frame: Patients' LIT scores in relative light units (RLU) within 24 hours following the day of hospitalization during the study period
  description: the difference of the Leukocyte ImmunoTest™ (LIT) as relative light unit (RLU) between patients with various infection conditions and control groups without infection.
  Abnormally high (hyperproduction) ROS generation demonstrated via The Leukocyte ImmunoTest™ (LIT) is associated with infection. LIT scores as relative light unit (RLU) can vary between 1-15000.
  measure: the reactive oxygen species (ROS) production of neutrophils via the Leukocyte ImmunoTest™ (LIT)
  time frame: LIT score as as relative light unit (RLU) of the day of detecting of infection and sepsis up to 8 months
  description: the difference of the Leukocyte ImmunoTest™ (LIT) as relative light unit (RLU) between patients between sepsis and without sepsis
  Abnormally high (hyperproduction) ROS generation demonstrated via The Leukocyte ImmunoTest™ (LIT) is associated with sepsis and septic shock. LIT scores as relative light unit (RLU) can vary between 1-15000.
  measure: the reactive oxygen species (ROS) production of neutrophils via the Leukocyte ImmunoTest™ (LIT)
  time frame: the Leukocyte ImmunoTest™ (LIT) as relative light unit (RLU) of the patients with sepsis on every day or every other day up to death or discharge from the hospital through the study completion, an average of 8 months
  description: the difference of the Leukocyte ImmunoTest™ (LIT) as relative light unit (RLU) between survivors and nonsurvivors within the septic patients.
  Abnormally high (hyperproduction) ROS generation demonstrated via The Leukocyte ImmunoTest™ (LIT) is associated with infection, sepsis and septic shock. LIT scores as relative light unit (RLU) can vary between 1-15000. The relationship of high scores of the LIT as relative light unit (RLU) with mortality will be evaluated.
  arm group label: patient group
  description: patients admitted to hospital with various infection conditions with or without sepsis
  arm group label: control group
  description: patients admitted to hospital with various non-infectious diseases and outpatients who admitted to the outpatient clinics
  intervention type: Diagnostic Test
  intervention name: The Leukocyte ImmunoTest™ (LIT™)
  description: The baseline LIT scores was performed for two parallel groups. The sequential LIT score was also performed for patients with various infection conditions with/without sepsis.
  arm group label: control group
  arm group label: patient group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nazlıhan Boyacı Dündar, assist.prof.
  role: Principal Investigator
  affiliation: principle investigator
  facility: 
  country: Turkey
  citation: Mortaz E, Alipoor SD, Adcock IM, Mumby S, Koenderman L. Update on Neutrophil Function in Severe Inflammation. Front Immunol. 2018 Oct 2;9:2171. doi: 10.3389/fimmu.2018.02171. eCollection 2018.
  PMID: 30356867
  citation: Selders GS, Fetz AE, Radic MZ, Bowlin GL. An overview of the role of neutrophils in innate immunity, inflammation and host-biomaterial integration. Regen Biomater. 2017 Feb;4(1):55-68. doi: 10.1093/rb/rbw041.
  PMID: 28149530
  citation: Hellebrekers P, Vrisekoop N, Koenderman L. Neutrophil phenotypes in health and disease. Eur J Clin Invest. 2018 Nov;48 Suppl 2(Suppl Suppl 2):e12943. doi: 10.1111/eci.12943. Epub 2018 May 25.
  PMID: 29682724
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  responsible party type: Principal Investigator
  investigator affiliation: Gazi University
  investigator full name: Nazlıhan Boyacı Dündar
  investigator title: assistan professor, Division of Intensive Care Medicine (principle invastigator)
  mesh term: Sepsis
  mesh term: Toxemia
  mesh term: Shock, Septic
  mesh term: Shock
  sharing ipd: No