<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/NCT03819959</url>
  </required_header>
  <id_info>
    <org_study_id>MIRACLE II</org_study_id>
    <nct_id>NCT03819959</nct_id>
  </id_info>
  <brief_title>Metabolomics Study on Intensive Care Acquired Muscle Weakness in Polytrauma</brief_title>
  <acronym>MIRACLE II</acronym>
  <official_title>Metabolomics Pilot Study on Intensive Care Acquired Muscle Weakness in Polytrauma (MIRACLE-II Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helmholtz Zentrum München</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Technical University of Munich</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>
      In this mono-center pilot trial, polytrauma patients admitted to intensive care will be&#xD;
      included. Investigators are going to take blood and muscle samples at respecified time points&#xD;
      to do metabolic, histological and molecular testing.&#xD;
&#xD;
      Aim of the study is to investigate (1) changes of the blood metabolome in patients with ICUAW&#xD;
      (intensive care unit acquired weakness) and (2) identify metabolic components who are&#xD;
      responsible for ICUAW or can be used as marker for ICUAW.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 24, 2019</start_date>
  <completion_date type="Actual">April 22, 2020</completion_date>
  <primary_completion_date type="Actual">April 22, 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>Metabolomics</measure>
    <time_frame>a median of 14 days</time_frame>
    <description>Blood Metabolome will be isolated from blood samples. All samples will be screened for changes in the blood metabolome during muscle wasting (i.e. Intensive Care Unit Acquired Weakness) using mass spectrometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle histology</measure>
    <time_frame>a median of 14 days</time_frame>
    <description>Immunohistochemistry will be done in muscle samples. All samples will be screened for changes in the muscular structure and correlation with blood metabolome changes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phosphoproteomics</measure>
    <time_frame>a median of 14 days</time_frame>
    <description>Phosphoproteomics will be done in muscle samples using mass spectrometry. All samples will be screened for influence of muscular changes (i.e. Intensive Care Unit Acquired Weakness (ICUAW)) and correlation with blood metabolome changes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Identify possible predictors of muscle wasting in the blood metabolome at ICU admission</measure>
    <time_frame>a median of 14 days</time_frame>
    <description>Identify metabolites or combinations of metabolites whose high or low concentration(s) at ICU admission associate(s) with the amount of muscle loss. These metabolites are candidate biomarkers that could be used to identify individuals at risk of large muscle wasting and may give further insights into the mechanisms of muscle wasting.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Metabolomics</condition>
  <condition>Critical Care</condition>
  <condition>Critical Illness</condition>
  <condition>Critical Illness Myopathy</condition>
  <condition>Critical Illness Polyneuropathy</condition>
  <condition>Intensive Care (ICU) Myopathy</condition>
  <condition>Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>Intensive Care Patients</arm_group_label>
    <description>Polytrauma patients who have been admitted to intensive care</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  Blood&#xD;
&#xD;
        -  Skeletal muscle biopsy&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        polytrauma patients who are admitted to intensive care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  acute polytrauma patient&#xD;
&#xD;
          -  age ≥ 18 years old&#xD;
&#xD;
          -  expected intensive care stay ≥ 3 days&#xD;
&#xD;
          -  American Society of Anesthesiologists classification I or II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient had received cardiopulmonary resuscitation&#xD;
&#xD;
          -  limitation of therapy or comfort care&#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>Stefan J Schaller, MD, MHBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Technical University of Munich</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hennig Wackerhage, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Technical University of Munich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum rechts der Isar, School of Medicine, Technical University of Munich</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>October 4, 2020</last_update_submitted>
  <last_update_submitted_qc>October 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Technical University of Munich</investigator_affiliation>
    <investigator_full_name>Stefan Schaller</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pilot Trial</keyword>
  <keyword>Muscle Biopsy</keyword>
  <keyword>Blood Metabolome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Diseases</mesh_term>
    <mesh_term>Muscle Weakness</mesh_term>
    <mesh_term>Polyneuropathies</mesh_term>
    <mesh_term>Paresis</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Asthenia</mesh_term>
    <mesh_term>Multiple Trauma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03819959
org study id: MIRACLE II
nct id: NCT03819959
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this mono-center pilot trial, polytrauma patients admitted to intensive care will be
      included. Investigators are going to take blood and muscle samples at respecified time points
      to do metabolic, histological and molecular testing.

      Aim of the study is to investigate (1) changes of the blood metabolome in patients with ICUAW
      (intensive care unit acquired weakness) and (2) identify metabolic components who are
      responsible for ICUAW or can be used as marker for ICUAW.
observational model: Cohort
time perspective: Prospective
measure: Metabolomics
time frame: a median of 14 days
description: Blood Metabolome will be isolated from blood samples. All samples will be screened for changes in the blood metabolome during muscle wasting (i.e. Intensive Care Unit Acquired Weakness) using mass spectrometry
measure: Muscle histology
time frame: a median of 14 days
description: Immunohistochemistry will be done in muscle samples. All samples will be screened for changes in the muscular structure and correlation with blood metabolome changes.
measure: Phosphoproteomics
time frame: a median of 14 days
description: Phosphoproteomics will be done in muscle samples using mass spectrometry. All samples will be screened for influence of muscular changes (i.e. Intensive Care Unit Acquired Weakness (ICUAW)) and correlation with blood metabolome changes.
measure: Identify possible predictors of muscle wasting in the blood metabolome at ICU admission
time frame: a median of 14 days
description: Identify metabolites or combinations of metabolites whose high or low concentration(s) at ICU admission associate(s) with the amount of muscle loss. These metabolites are candidate biomarkers that could be used to identify individuals at risk of large muscle wasting and may give further insights into the mechanisms of muscle wasting.
arm group label: Intensive Care Patients
description: Polytrauma patients who have been admitted to intensive care
-  Blood

        -  Skeletal muscle biopsy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefan J Schaller, MD, MHBA
role: Principal Investigator
affiliation: Technical University of Munich
last name: Hennig Wackerhage, PhD
role: Principal Investigator
affiliation: Technical University of Munich
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Technical University of Munich
investigator full name: Stefan Schaller
investigator title: Principal Investigator
mesh term: Muscular Diseases
mesh term: Muscle Weakness
mesh term: Polyneuropathies
mesh term: Paresis
mesh term: Critical Illness
mesh term: Asthenia
mesh term: Multiple Trauma
sharing ipd: Undecided