<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/NCT03038919</url>
  </required_header>
  <id_info>
    <org_study_id>16-0293</org_study_id>
    <nct_id>NCT03038919</nct_id>
  </id_info>
  <brief_title>Role of Anabolic Steroids on Intensive Care Unit-Acquired Weakness</brief_title>
  <acronym>RAS-ICU</acronym>
  <official_title>Pilot Randomized, Controlled Trial of Testosterone Therapy in Chronic Critically Ill Patients and Its Potential Effects on Weaning From Mechanical Ventilation and Intensive Care Unit-acquired Weakness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The researchers intend to investigate possible anabolic effects of bi-weekly exogenous&#xD;
      testosterone administration during intensive care unit (ICU) stay for up to 8 weeks. Control&#xD;
      group will receive standard ICU management and will also be followed during ICU stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For the study chronic critical patients will be included according to criterion of mechanical&#xD;
      ventilation by orotracheal tube&gt; 14 consecutive days or mechanical ventilation by&#xD;
      tracheostomy&gt; 8 consecutive days and that do not present exclusion criteria.&#xD;
&#xD;
      Patients will be randomized into two follow-up groups: Intervention group with anabolic&#xD;
      steroid and control group.&#xD;
&#xD;
      The anabolic steroid intervention group will receive a bi-weekly dose of 200mg intramuscular&#xD;
      testosterone cypionate and receive the standard treatment of nutritional therapy and physical&#xD;
      therapy. While patients in the control group will receive only the standard treatment of&#xD;
      nutrition and physical therapy, without addition of the anabolic drug.&#xD;
&#xD;
      At the beginning of the study and weekly the patients will be evaluated in relation to the&#xD;
      muscular profile with diaphragm ultrasound and Medical Research Council (MRC) application. In&#xD;
      addition to the collection of serum homograms, leukogram, lipid profile and renal function&#xD;
      tests.&#xD;
&#xD;
      Weight and nutritional therapy-related data will be identified in the patient's chart&#xD;
      regarding caloric and protein requirement and supply adequacy.&#xD;
&#xD;
      In the inclusion and biweekly will be collected serum levels of free testosterone, blood&#xD;
      count, leukogram, blood gas, renal function and liver function. Nitrogen balance of patients&#xD;
      from urinary urea will be performed.&#xD;
&#xD;
      The evaluations of the groups and the intervention with the anabolic steroid will be of 8&#xD;
      weeks or during the period of dependence of the mechanical ventilation. After this period the&#xD;
      patients will be monitored for the outcome: length of stay in the intensive care unit,&#xD;
      hospital stay until discharge and clinical outcome: death or discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mechanical ventilation dependence</measure>
    <time_frame>8 weeks</time_frame>
    <description>Days of any positive pressure ventilation described in the patient record from the start of the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle weakness</measure>
    <time_frame>8 weeks</time_frame>
    <description>The muscle weakness measured weekly by the study team through the Medical Research Council (MRC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasound diaphragm</measure>
    <time_frame>8 weeks</time_frame>
    <description>Weekly the study team will perform diaphragm ultrasound to monitor the respiratory muscles, observing measures of inspiration and expiration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>9 months</time_frame>
    <description>Patient's length of stay in the intensive care unit after the start of the study as described in the patient record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>9 months</time_frame>
    <description>Period of stay of the patient in the hospital after discharge from the intensive care unit described in the patient record</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Critical Illness Polyneuropathies</condition>
  <arm_group>
    <arm_group_label>Anabolic patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intramuscular injection of testosterone cypionate 200mg every 15 days in addition to standard nutrition and physical therapy at ICU.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard nutrition and physical therapy at ICU without administration of testosterone cypionate</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Testosterone cypionate</intervention_name>
    <description>Bi-weekly intramuscular injection of testosterone cypionate 200mg.</description>
    <arm_group_label>Anabolic patients</arm_group_label>
    <other_name>testosterone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard nutrition and physical therapy at ICU</intervention_name>
    <description>follow-up of the patient without use of testosterone cypionate</description>
    <arm_group_label>Anabolic patients</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals older than 18 years&#xD;
&#xD;
          -  Mechanical ventilation by orotracheal tube for more than 14 consecutive days&#xD;
&#xD;
          -  Mechanical ventilation by tracheostomy for more than 8 consecutive days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  End of life care&#xD;
&#xD;
          -  Known hypersensitivity to formula&#xD;
&#xD;
          -  Venous or arterial thrombosis within last 6 months: ischemic stroke, myocardial&#xD;
             infarction, acute peripheral arterial occlusion, acute mesenteric ischemia, deep&#xD;
             venous thromboembolism, pulmonary embolism&#xD;
&#xD;
          -  Decompensated congestive heart failure&#xD;
&#xD;
          -  Acute liver failure or acute on chronic liver failure&#xD;
&#xD;
          -  Refractory shock (norepinephrine dose &gt;0.3 mcg/kg/min or equivalent doses of any&#xD;
             vasoactive agent)&#xD;
&#xD;
          -  Platelets below &lt;20,000 / mm3 without transfusion plan&#xD;
&#xD;
          -  Personal history of prostate cancer&#xD;
&#xD;
          -  Primary neuromuscular disorders such as myasthenia gravis, Guillain-Barré syndrome,&#xD;
             amyotrophic lateral sclerosis, Duchenne Muscular dystrophy&#xD;
&#xD;
          -  Current or prior spinal cord injury&#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>Silvia RR Vieira, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre - RS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sara C Rosa</last_name>
    <phone>+5551997381047</phone>
    <email>sararosa92@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ana Carolina P Antonio, PhD</last_name>
    <phone>+5551984428820</phone>
    <email>ana.carolina.antonio@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ana Carolina P Antonio, PhD</last_name>
      <phone>+555133598000</phone>
      <phone_ext>8637</phone_ext>
      <email>aantonio@hcpa.edu.br</email>
    </contact>
    <contact_backup>
      <last_name>Sara C Rosa</last_name>
      <phone>+555133598000</phone>
      <phone_ext>8637</phone_ext>
      <email>sararosa92@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Sara C da Rosa</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ana Carolina P Antonio, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Silvia RR Vieira, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prolonged mechanical ventilation</keyword>
  <keyword>critically ill patients</keyword>
  <keyword>anabolic steroid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyneuropathies</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methyltestosterone</mesh_term>
    <mesh_term>Testosterone</mesh_term>
    <mesh_term>Testosterone undecanoate</mesh_term>
    <mesh_term>Testosterone enanthate</mesh_term>
    <mesh_term>Testosterone 17 beta-cypionate</mesh_term>
  </intervention_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/NCT03038919
org study id: 16-0293
nct id: NCT03038919
lead sponsor: 
has dmc: No
The researchers intend to investigate possible anabolic effects of bi-weekly exogenous
      testosterone administration during intensive care unit (ICU) stay for up to 8 weeks. Control
      group will receive standard ICU management and will also be followed during ICU stay.
For the study chronic critical patients will be included according to criterion of mechanical
      ventilation by orotracheal tube> 14 consecutive days or mechanical ventilation by
      tracheostomy> 8 consecutive days and that do not present exclusion criteria.

      Patients will be randomized into two follow-up groups: Intervention group with anabolic
      steroid and control group.

      The anabolic steroid intervention group will receive a bi-weekly dose of 200mg intramuscular
      testosterone cypionate and receive the standard treatment of nutritional therapy and physical
      therapy. While patients in the control group will receive only the standard treatment of
      nutrition and physical therapy, without addition of the anabolic drug.

      At the beginning of the study and weekly the patients will be evaluated in relation to the
      muscular profile with diaphragm ultrasound and Medical Research Council (MRC) application. In
      addition to the collection of serum homograms, leukogram, lipid profile and renal function
      tests.

      Weight and nutritional therapy-related data will be identified in the patient's chart
      regarding caloric and protein requirement and supply adequacy.

      In the inclusion and biweekly will be collected serum levels of free testosterone, blood
      count, leukogram, blood gas, renal function and liver function. Nitrogen balance of patients
      from urinary urea will be performed.

      The evaluations of the groups and the intervention with the anabolic steroid will be of 8
      weeks or during the period of dependence of the mechanical ventilation. After this period the
      patients will be monitored for the outcome: length of stay in the intensive care unit,
      hospital stay until discharge and clinical outcome: death or discharge.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mechanical ventilation dependence
time frame: 8 weeks
description: Days of any positive pressure ventilation described in the patient record from the start of the study
measure: Muscle weakness
time frame: 8 weeks
description: The muscle weakness measured weekly by the study team through the Medical Research Council (MRC)
measure: Ultrasound diaphragm
time frame: 8 weeks
description: Weekly the study team will perform diaphragm ultrasound to monitor the respiratory muscles, observing measures of inspiration and expiration.
measure: ICU length of stay
time frame: 9 months
description: Patient's length of stay in the intensive care unit after the start of the study as described in the patient record
measure: Hospital length of stay
time frame: 9 months
description: Period of stay of the patient in the hospital after discharge from the intensive care unit described in the patient record
arm group label: Anabolic patients
arm group type: Experimental
description: Intramuscular injection of testosterone cypionate 200mg every 15 days in addition to standard nutrition and physical therapy at ICU.
arm group label: Control
arm group type: Other
description: Standard nutrition and physical therapy at ICU without administration of testosterone cypionate
intervention type: Drug
intervention name: Testosterone cypionate
description: Bi-weekly intramuscular injection of testosterone cypionate 200mg.
arm group label: Anabolic patients
other name: testosterone
intervention type: Other
intervention name: Standard nutrition and physical therapy at ICU
description: follow-up of the patient without use of testosterone cypionate
arm group label: Anabolic patients
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Silvia RR Vieira, PhD
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre - RS
last name: Sara C Rosa
phone: +5551997381047
email: sararosa92@gmail.com
last name: Ana Carolina P Antonio, PhD
phone: +5551984428820
email: ana.carolina.antonio@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Brazil
responsible party type: Sponsor
mesh term: Polyneuropathies
mesh term: Critical Illness
mesh term: Methyltestosterone
mesh term: Testosterone
mesh term: Testosterone undecanoate
mesh term: Testosterone enanthate
mesh term: Testosterone 17 beta-cypionate
sharing ipd: Undecided