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/NCT06036056</url>
    </required_header>
    <id_info>
      <org_study_id>2023-223-CP-133</org_study_id>
      <nct_id>NCT06036056</nct_id>
    </id_info>
    <brief_title>NMR Based Metabolomics Kinetics in ARDS Patients</brief_title>
    <official_title>NMR - Based Metabolomics Approach to Improve Clinical Management in Patients With Respiratory Failure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sanjay Gandhi Postgraduate Institute of Medical Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centre of BioMedical Research, India</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Sanjay Gandhi Postgraduate Institute of Medical Sciences</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>
        Acute respiratory distress syndrome (ARDS) is a life-threatening condition requiring&#xD;
        respiratory support to maintain oxygenation. Very few biomarkers about ARDS have been&#xD;
        identified but none of them has a sufficient specificity or sensitivity to characterize by&#xD;
        itself the severity of lung condition. Investigators hypothesize that there is considerable&#xD;
        change occurring in metabolic profiles in mild, moderate, and severe ARDS in comparison to&#xD;
        healthy cohort, which can be detectable through serum analysis using NMR based metabolomics&#xD;
        study. This research would help to understand metabolomics kinetics during the ARDS disease&#xD;
        progression. Overall, NMR-based metabolomics study would provide an insight into the&#xD;
        mediators involved in pathogenesis and progression of ARDS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        For this study, all adult ICU patients will be screened for ARDS. Participants who fulfill&#xD;
        criteria of mild ARDS (PaO2/FiO2 200-300) will be considered for possible inclusion. For&#xD;
        comparative analysis, age matched healthy control will also be included in the study.&#xD;
        Investigators are planning to work on the blood samples collected from the participants&#xD;
        having mild ARDS. First samples will be collected within 72 hours of fulfilling diagnostic&#xD;
        criteria of mild ARDS, thereafter every 72 hours till participants recovered from ARDS or&#xD;
        discharge from the ICU or three weeks after inclusion, whichever comes first. For serum&#xD;
        preparation, 2 ml of blood samples will be obtained in collection vial, allowed to clot for&#xD;
        60 minutes at room temperature. The samples will then be centrifuged at 1,200 × g for 10&#xD;
        minutes, collected in an eppendorf tubes, sealed and frozen at minus 80 degree Celsius till&#xD;
        NMR experiments would be performed. Further 1D and 2D NMR spectroscopic techniques will be&#xD;
        used for the characterization and quantitation of various metabolic components of serum.&#xD;
  &#xD;
        This study is exploratory in nature to understand kinetics of NMR-based metabolomics in ARDS&#xD;
        population. Considering approximately 20-25% of mild ARDS will eventually progress to severe&#xD;
        ARDS, investigators will include total 120 participants (including healthy participants).&#xD;
        Data collection for comprehends demographic profile, clinical characteristics and illness&#xD;
        severity score Sequential Organ Failure Assessment (SOFA) score at the time of study&#xD;
        inclusion, clinical course during ICU stay and participants outcome will be done.&#xD;
  &#xD;
        NMR spectroscopy (800-MHz Bruker) of sample will be performed using an external tube&#xD;
        containing Trimethylsilyl propanoic acid (TSP), D2O to lock the signal. Plasma/Serum samples&#xD;
        will be thawed and subsequently centrifuged at 10,000g for 5 min at 4°C to remove any solid&#xD;
        debris, 450 μl of each sample will be thoroughly mixed with 50 μl of NMR buffer (1.5 MKH2PO4,&#xD;
        2 mM NaN3, 5.8 mM sodium 3-(trimethylsilyl) propionate-2,2,3,3-d4, D2O, pH 7.4) and the&#xD;
        resulting solution will be transferred to 5 mm or 3 mm NMR tubes. All one-dimensional spectra&#xD;
        with water suppression will be obtained. Proton spectra will be referenced to the TSP signal&#xD;
        (δ=0.00 ppm). The Free induction decays (FIDs) will be processed with line broadening and&#xD;
        zero filled before Fourier transformation. The acquired spectra will be manually phased;&#xD;
        baseline corrected and integrated using TOPSPIN 2.1.&#xD;
  &#xD;
        All NMR spectra will be processed and analysed using TOPSIN 3 package. Auto and supervised&#xD;
        peak picking will be performed with Amix and metabolites identification will be done using&#xD;
        Metaboanlayst and BIOREFCODE database of metabolites. Standard statistical supervised and&#xD;
        unsupervised multivariate analysis (PCA and PLSDA) will be performed.&#xD;
  &#xD;
        Metabolites in the 1H NMR spectra of serum samples will be assigned using 1D, 2D, HMDB and&#xD;
        BMRB database. Small metabolite overlapping resonances present in 1D spectrum will be&#xD;
        confirmed by using 2D spectra including heteronuclear single quantum correlation (HSQC),&#xD;
        correlation spectroscopy (COSY), Total correlation spectroscopy (TOCSY), J-resolved (JRES)&#xD;
        and Human Metabolome Database and Biological magnetic resonance bank (BMRB) database.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 13, 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2025</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>To identify the potential biomarkers in mild ARDS using NMR based metabolomics</measure>
      <time_frame>Up to the 72 hours after the diagnosis of mild ARDS</time_frame>
      <description>NMR based metabolomics in the serum of patients with mild ARDS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To study the kinetics of NMR based metabolomics in mild ARDS and its association with progression of ARDS severity.</measure>
      <time_frame>Three weeks after diagnosing mild ARDS or till ICU discharge (whichever comes first)</time_frame>
      <description>Changes in NMR based metabolomics in serum of patients with mild ARDS</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlation of the infection etiology and NMR based metabolomics</measure>
      <time_frame>Up to the three weeks after the diagnosis of mild ARDS or ICU discharge (whichever comes first)</time_frame>
      <description>To study microorganism specific changes in NMR based metabolomics, if any</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>ARDS</condition>
    <arm_group>
      <arm_group_label>Acute Respiratory Distress Syndrome</arm_group_label>
      <description>Mild Acute Respiratory Distress Syndrome</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy</arm_group_label>
      <description>Healthy volunteer</description>
    </arm_group>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Serum of participants will be stored for future research&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who fulfill criteria of mild ARDS (PaO2/FiO2 200-300) will be considered for&#xD;
          possible inclusion. For comparative analysis, age matched healthy control (from healthy&#xD;
          blood donor volunteer will also be included in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Critically ill adult patients having mild ARDS with onset less than 72 hours&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age less than 18 years or more than 65 years&#xD;
  &#xD;
            -  Expected survival &lt;72 hours&#xD;
  &#xD;
            -  Refusal from family member&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Neeraj Sinha, M.Sc., Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centre of Biomedical Research</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mohan Gurjar, MD, PDCC</last_name>
      <phone>+91-522-249-5403</phone>
      <email>m.gurjar@rediffmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Neeraj Sinha, M.Sc., Ph.D.</last_name>
      <phone>05222495031</phone>
      <email>neerajcbmr@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Centre of Biomedical Research</name>
        <address>
          <city>Lucknow</city>
          <state>Uttar Pradesh</state>
          <zip>226014</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Neeraj Sinha, M.Sc., Ph.D.</last_name>
        <phone>05222495031</phone>
        <email>neerajcbmr@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Anamika Singh</last_name>
        <email>anamika95singh23@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sanjay Gandhi Postgraduate Institute of Medical Sciences</investigator_affiliation>
      <investigator_full_name>Mohan Gurjar</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Critically ill</keyword>
    <keyword>Acute respiratory distress syndrome</keyword>
    <keyword>Metabolomics</keyword>
    <keyword>Intensive care unit</keyword>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06036056
  org study id: 2023-223-CP-133
  nct id: NCT06036056
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Acute respiratory distress syndrome (ARDS) is a life-threatening condition requiring
        respiratory support to maintain oxygenation. Very few biomarkers about ARDS have been
        identified but none of them has a sufficient specificity or sensitivity to characterize by
        itself the severity of lung condition. Investigators hypothesize that there is considerable
        change occurring in metabolic profiles in mild, moderate, and severe ARDS in comparison to
        healthy cohort, which can be detectable through serum analysis using NMR based metabolomics
        study. This research would help to understand metabolomics kinetics during the ARDS disease
        progression. Overall, NMR-based metabolomics study would provide an insight into the
        mediators involved in pathogenesis and progression of ARDS.
  For this study, all adult ICU patients will be screened for ARDS. Participants who fulfill
        criteria of mild ARDS (PaO2/FiO2 200-300) will be considered for possible inclusion. For
        comparative analysis, age matched healthy control will also be included in the study.
        Investigators are planning to work on the blood samples collected from the participants
        having mild ARDS. First samples will be collected within 72 hours of fulfilling diagnostic
        criteria of mild ARDS, thereafter every 72 hours till participants recovered from ARDS or
        discharge from the ICU or three weeks after inclusion, whichever comes first. For serum
        preparation, 2 ml of blood samples will be obtained in collection vial, allowed to clot for
        60 minutes at room temperature. The samples will then be centrifuged at 1,200 × g for 10
        minutes, collected in an eppendorf tubes, sealed and frozen at minus 80 degree Celsius till
        NMR experiments would be performed. Further 1D and 2D NMR spectroscopic techniques will be
        used for the characterization and quantitation of various metabolic components of serum.
  
        This study is exploratory in nature to understand kinetics of NMR-based metabolomics in ARDS
        population. Considering approximately 20-25% of mild ARDS will eventually progress to severe
        ARDS, investigators will include total 120 participants (including healthy participants).
        Data collection for comprehends demographic profile, clinical characteristics and illness
        severity score Sequential Organ Failure Assessment (SOFA) score at the time of study
        inclusion, clinical course during ICU stay and participants outcome will be done.
  
        NMR spectroscopy (800-MHz Bruker) of sample will be performed using an external tube
        containing Trimethylsilyl propanoic acid (TSP), D2O to lock the signal. Plasma/Serum samples
        will be thawed and subsequently centrifuged at 10,000g for 5 min at 4°C to remove any solid
        debris, 450 μl of each sample will be thoroughly mixed with 50 μl of NMR buffer (1.5 MKH2PO4,
        2 mM NaN3, 5.8 mM sodium 3-(trimethylsilyl) propionate-2,2,3,3-d4, D2O, pH 7.4) and the
        resulting solution will be transferred to 5 mm or 3 mm NMR tubes. All one-dimensional spectra
        with water suppression will be obtained. Proton spectra will be referenced to the TSP signal
        (δ=0.00 ppm). The Free induction decays (FIDs) will be processed with line broadening and
        zero filled before Fourier transformation. The acquired spectra will be manually phased;
        baseline corrected and integrated using TOPSPIN 2.1.
  
        All NMR spectra will be processed and analysed using TOPSIN 3 package. Auto and supervised
        peak picking will be performed with Amix and metabolites identification will be done using
        Metaboanlayst and BIOREFCODE database of metabolites. Standard statistical supervised and
        unsupervised multivariate analysis (PCA and PLSDA) will be performed.
  
        Metabolites in the 1H NMR spectra of serum samples will be assigned using 1D, 2D, HMDB and
        BMRB database. Small metabolite overlapping resonances present in 1D spectrum will be
        confirmed by using 2D spectra including heteronuclear single quantum correlation (HSQC),
        correlation spectroscopy (COSY), Total correlation spectroscopy (TOCSY), J-resolved (JRES)
        and Human Metabolome Database and Biological magnetic resonance bank (BMRB) database.
  observational model: Cohort
  time perspective: Prospective
  measure: To identify the potential biomarkers in mild ARDS using NMR based metabolomics
  time frame: Up to the 72 hours after the diagnosis of mild ARDS
  description: NMR based metabolomics in the serum of patients with mild ARDS
  measure: To study the kinetics of NMR based metabolomics in mild ARDS and its association with progression of ARDS severity.
  time frame: Three weeks after diagnosing mild ARDS or till ICU discharge (whichever comes first)
  description: Changes in NMR based metabolomics in serum of patients with mild ARDS
  measure: Correlation of the infection etiology and NMR based metabolomics
  time frame: Up to the three weeks after the diagnosis of mild ARDS or ICU discharge (whichever comes first)
  description: To study microorganism specific changes in NMR based metabolomics, if any
  arm group label: Acute Respiratory Distress Syndrome
  description: Mild Acute Respiratory Distress Syndrome
  arm group label: Healthy
  description: Healthy volunteer
  Serum of participants will be stored for future research
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Neeraj Sinha, M.Sc., Ph.D.
  role: Principal Investigator
  affiliation: Centre of Biomedical Research
  last name: Mohan Gurjar, MD, PDCC
  phone: +91-522-249-5403
  email: m.gurjar@rediffmail.com
  last name: Neeraj Sinha, M.Sc., Ph.D.
  phone: 05222495031
  email: neerajcbmr@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: India
  responsible party type: Principal Investigator
  investigator affiliation: Sanjay Gandhi Postgraduate Institute of Medical Sciences
  investigator full name: Mohan Gurjar
  investigator title: Professor
  sharing ipd: Undecided