<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/NCT03810768</url>
  </required_header>
  <id_info>
    <org_study_id>MIRACLE I</org_study_id>
    <nct_id>NCT03810768</nct_id>
  </id_info>
  <brief_title>Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness</brief_title>
  <acronym>MIRACLE I</acronym>
  <official_title>Metabolomics Pilot Study on Postoperative Intensive Care Acquired Muscle Weakness (MIRACLE-I 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>
    <collaborator>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</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, surgical patients who are at high risk to be admitted to&#xD;
      intensive care will be screened and asked for participation. We are going to take blood and&#xD;
      muscle samples at respecified time points to do metabolic, histological and molecular&#xD;
      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>Recruiting</overall_status>
  <start_date type="Actual">September 2, 2022</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 1, 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>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 influence of Intensive Care Unit Acquired Weakness (ICUAW) 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 influence of Intensive Care Unit Acquired Weakness (ICUAW) 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 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 preoperatively</measure>
    <time_frame>a median of 14 days</time_frame>
    <description>Among the blood metabolome that will be measured, identify metabolites or combinations of metabolites whose high or low concentration(s) preoperatively 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>
  <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>Among the blood metabolome that will be measured, 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>2</number_of_groups>
  <enrollment type="Anticipated">20</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>Postoperative high-risk patients who have been admitted to intensive care after surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Operative Control patients</arm_group_label>
    <description>Elective operative patients where control blood samples and muscle ultrasound will be measured.</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>
        mechanically ventilated postoperative high-risk patients who are admitted to intensive care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  invasive mechanically ventilated critically ill patient with expected intensive care&#xD;
             unit stay &gt; 3 days&#xD;
&#xD;
          -  postoperative patient&#xD;
&#xD;
          -  ≥ 18 years old&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) classification ≥ III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  moribund patient&#xD;
&#xD;
          -  non-curative care (comfort care)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Stefan J Schaller, MD</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>
  <overall_contact>
    <last_name>Stefan J Schaller, MD</last_name>
    <phone>+49-89-4140-9635</phone>
    <email>s.schaller@tum.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Manfred Blobner, MD</last_name>
    <phone>+49-89-4140-7206</phone>
    <email>m.blobner@tum.de</email>
  </overall_contact_backup>
  <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>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Stefan J Schaller, MD</last_name>
      <phone>+49-89-4140-9635</phone>
      <email>s.schaller@tum.de</email>
    </contact>
    <contact_backup>
      <last_name>Manfred Blobner, MD</last_name>
      <phone>+49-89-4140-7206</phone>
      <email>m.blobner@tum.de</email>
    </contact_backup>
    <investigator>
      <last_name>Stefan J Schaller, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Henning Wackerhage, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Manfred Blobner, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jürgen Schlegel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kristina Fuest, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefan J Schaller, MD</last_name>
      <phone>+49-30-450-531052</phone>
      <email>stefan.schaller@charite.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>September 17, 2022</last_update_submitted>
  <last_update_submitted_qc>September 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</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>
  </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/NCT03810768
org study id: MIRACLE I
nct id: NCT03810768
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this mono-center pilot trial, surgical patients who are at high risk to be admitted to
      intensive care will be screened and asked for participation. We 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 influence of Intensive Care Unit Acquired Weakness (ICUAW) 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 influence of Intensive Care Unit Acquired Weakness (ICUAW) 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 Intensive Care Unit Acquired Weakness (ICUAW) and correlation with blood metabolome changes.
measure: Identify possible predictors of muscle wasting in the blood metabolome preoperatively
time frame: a median of 14 days
description: Among the blood metabolome that will be measured, identify metabolites or combinations of metabolites whose high or low concentration(s) preoperatively 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.
measure: Identify possible predictors of muscle wasting in the blood metabolome at ICU admission
time frame: a median of 14 days
description: Among the blood metabolome that will be measured, 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: Postoperative high-risk patients who have been admitted to intensive care after surgery
arm group label: Operative Control patients
description: Elective operative patients where control blood samples and muscle ultrasound will be measured.
-  Blood

        -  Skeletal muscle biopsy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Stefan J Schaller, MD
role: Principal Investigator
affiliation: Technical University of Munich
last name: Hennig Wackerhage, PhD
role: Principal Investigator
affiliation: Technical University of Munich
last name: Stefan J Schaller, MD
phone: +49-89-4140-9635
email: s.schaller@tum.de
last name: Manfred Blobner, MD
phone: +49-89-4140-7206
email: m.blobner@tum.de
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
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
sharing ipd: Undecided