<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/NCT02974257</url>
  </required_header>
  <id_info>
    <org_study_id>2016P000347</org_study_id>
    <secondary_id>1K23HL128814-01A1</secondary_id>
    <nct_id>NCT02974257</nct_id>
  </id_info>
  <brief_title>Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest</brief_title>
  <official_title>Randomized, Double-blind, Placebo-controlled Trial of the Effect of Thiamine on Oxygen Consumption After In-hospital Cardiac Arrest.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate whether thiamine can increase oxygen consumption and lower lactate&#xD;
      in patients who initially survive an in-hospital cardiac arrest. Patients who are&#xD;
      successfully resuscitated after an in-hospital cardiac arrest and who are on mechanical&#xD;
      ventilation in the intensive care unit will be enrolled, and will get either thiamine or&#xD;
      placebo. Their oxygen consumption and lactate will be measured at serial time points and&#xD;
      compared between groups. The investigators' hypothesis is that thiamine will help restore the&#xD;
      body's ability to metabolize oxygen normally (aerobic metabolism), leading to an increase in&#xD;
      oxygen consumption and a decrease in lactate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In-hospital cardiac arrest often leads to shock and organ failure, and low oxygen consumption&#xD;
      and high lactate are associated with worse outcome. Thiamine is a B vitamin necessary to&#xD;
      maintain the body's ability to use oxygen effectively, and the investigators have found that&#xD;
      many patients are thiamine deficient after cardiac arrest. The investigators have also found&#xD;
      that thiamine can decrease lactate in thiamine-deficient patients who are critically ill.&#xD;
      Patients in this study will be randomized to receive either thiamine or placebo every 12&#xD;
      hours for 2 days after surviving an in-hospital cardiac arrest. The investigators will&#xD;
      measure oxygen consumption continuously during that time with a monitor attached to the&#xD;
      ventilator tubing, and will also measure lactate and other lab values at several time points.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study stopped early after consultation with DSMB&#xD;
  </why_stopped>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2022</completion_date>
  <primary_completion_date type="Actual">February 7, 2022</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>lactate</measure>
    <time_frame>2 days</time_frame>
    <description>The investigators will evaluate the absolute level and the change in lactate over two days, compared between groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>oxygen consumption</measure>
    <time_frame>2 days</time_frame>
    <description>The investigators will evaluate the absolute level and the change in oxygen consumption over two days, compared between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pyruvate dehydrogenase</measure>
    <time_frame>2 days</time_frame>
    <description>The investigators will evaluate the absolute level and the change in pyruvate dehydrogenase levels over two days, compared between groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Cardiac Arrest</condition>
  <condition>Shock</condition>
  <condition>Lactic Acidosis</condition>
  <condition>Thiamin Deficiency</condition>
  <arm_group>
    <arm_group_label>Thiamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Thiamine 500mg IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intervention: Placebo (100mL normal saline) IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thiamine</intervention_name>
    <description>Thiamine 500mg IV twice daily for 2 days</description>
    <arm_group_label>Thiamine</arm_group_label>
    <other_name>vitamin B1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>100mL normal saline IV every 12 hours for 2 days</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient (age &gt; 18 years)&#xD;
&#xD;
          -  Cardiac arrest occurring while admitted to the hospital, with sustained (&gt;20 minutes)&#xD;
             return of spontaneous circulation (ROSC)&#xD;
&#xD;
          -  Mechanically ventilated at the time of enrollment&#xD;
&#xD;
          -  Within 12 hours of cardiac arrest event&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical indication for thiamine administration (alcoholism, known or highly suspected&#xD;
             deficiency) or treatment with thiamine beyond the amount found in a standard&#xD;
             multivitamin within the last 10 days&#xD;
&#xD;
          -  Comfort measures only or anticipated withdrawal of support within 24 hours&#xD;
&#xD;
          -  Severe agitation&#xD;
&#xD;
          -  Protected populations (pregnant women, prisoners)&#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>Katherine M Berg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>August 5, 2022</last_update_submitted>
  <last_update_submitted_qc>August 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Katherine Berg</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>cardiac arrest</keyword>
  <keyword>thiamine</keyword>
  <keyword>oxygen consumption</keyword>
  <keyword>lactate</keyword>
  <keyword>shock</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Acidosis</mesh_term>
    <mesh_term>Acidosis, Lactic</mesh_term>
    <mesh_term>Thiamine Deficiency</mesh_term>
    <mesh_term>Beriberi</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thiamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 4, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT02974257/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>May 1, 2023</submitted>
    <returned>May 25, 2023</returned>
  </pending_results>
  <!-- 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/NCT02974257
org study id: 2016P000347
secondary id: 1K23HL128814-01A1
nct id: NCT02974257
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study is to evaluate whether thiamine can increase oxygen consumption and lower lactate
      in patients who initially survive an in-hospital cardiac arrest. Patients who are
      successfully resuscitated after an in-hospital cardiac arrest and who are on mechanical
      ventilation in the intensive care unit will be enrolled, and will get either thiamine or
      placebo. Their oxygen consumption and lactate will be measured at serial time points and
      compared between groups. The investigators' hypothesis is that thiamine will help restore the
      body's ability to metabolize oxygen normally (aerobic metabolism), leading to an increase in
      oxygen consumption and a decrease in lactate.
In-hospital cardiac arrest often leads to shock and organ failure, and low oxygen consumption
      and high lactate are associated with worse outcome. Thiamine is a B vitamin necessary to
      maintain the body's ability to use oxygen effectively, and the investigators have found that
      many patients are thiamine deficient after cardiac arrest. The investigators have also found
      that thiamine can decrease lactate in thiamine-deficient patients who are critically ill.
      Patients in this study will be randomized to receive either thiamine or placebo every 12
      hours for 2 days after surviving an in-hospital cardiac arrest. The investigators will
      measure oxygen consumption continuously during that time with a monitor attached to the
      ventilator tubing, and will also measure lactate and other lab values at several time points.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: lactate
time frame: 2 days
description: The investigators will evaluate the absolute level and the change in lactate over two days, compared between groups
measure: oxygen consumption
time frame: 2 days
description: The investigators will evaluate the absolute level and the change in oxygen consumption over two days, compared between groups
measure: Pyruvate dehydrogenase
time frame: 2 days
description: The investigators will evaluate the absolute level and the change in pyruvate dehydrogenase levels over two days, compared between groups
arm group label: Thiamine
arm group type: Experimental
description: Intervention: Thiamine 500mg IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
arm group label: Placebo
arm group type: Placebo Comparator
description: Intervention: Placebo (100mL normal saline) IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
intervention type: Drug
intervention name: Thiamine
description: Thiamine 500mg IV twice daily for 2 days
arm group label: Thiamine
other name: vitamin B1
intervention type: Other
intervention name: placebo
description: 100mL normal saline IV every 12 hours for 2 days
arm group label: Placebo
other name: normal saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katherine M Berg, MD
role: Principal Investigator
affiliation: Beth
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Katherine Berg
investigator title: Assistant Professor of Medicine
mesh term: Heart Arrest
mesh term: Acidosis
mesh term: Acidosis, Lactic
mesh term: Thiamine Deficiency
mesh term: Beriberi
mesh term: Thiamine
sharing ipd: No
provided document: 
submitted: May 1, 2023
returned: May 25, 2023