<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/NCT03021876</url>
  </required_header>
  <id_info>
    <org_study_id>LAMP study</org_study_id>
    <nct_id>NCT03021876</nct_id>
  </id_info>
  <brief_title>L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients</brief_title>
  <official_title>L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kochi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kochi University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      L-carnitine is synthesized from lysine and methionine. Postmortem concentrations of carnitine&#xD;
      in liver, muscle, heart, kidney, and brain averaged only one-fourth to one-third those in&#xD;
      corresponding tissues of eight normally nourished non-hepatic patients who died after an&#xD;
      acute illness of a 1-3-day duration. In the recent years, it has been reported that sirtuin 3&#xD;
      (SIRT3) is protective against acute kidney injury (AKI) and suggest that enhancing SIRT3 to&#xD;
      improve mitochondrial dynamics has potential as a strategy for improving outcomes of renal&#xD;
      injury. In the current study, it is the first clinical interventional research whether&#xD;
      L-carnitine corrects ammonia metabolism associated with liver injury in hepatectomized&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">April 2018</completion_date>
  <primary_completion_date type="Anticipated">April 2018</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>postoperative ammonia levels</measure>
    <time_frame>3 points; preoperative baseline, postoperative day 1, and day3</time_frame>
    <description>change from preoperative baseline at postoperative day 1 and day3</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>length of hospitalization after liver resection</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>postoperative days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Ammonia Metabolism</condition>
  <arm_group>
    <arm_group_label>ordinary group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>usual intake prior to liver surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>carnitine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>treatment with oral L-carnitine, 1500 mg/body per day for 2 weeks prior to liver surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>L-carnitine</intervention_name>
    <description>treatment with oral L-carnitine, 1500 mg/body per day</description>
    <arm_group_label>carnitine group</arm_group_label>
    <other_name>Carnitine group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>usual intake</intervention_name>
    <description>baseliner</description>
    <arm_group_label>ordinary group</arm_group_label>
    <other_name>Usual group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients were those surgically treated for hepato-biliary diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient exclusion criteria included a body weight loss greater than 10% during the six&#xD;
             months prior to surgery, the presence of distant metastases, or seriously impaired&#xD;
             function of vital organs due to respiratory, renal or heart disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Takehiro Okabayashi, MD</last_name>
    <phone>+81 88-837-3000</phone>
    <email>tokabaya@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kochi Health Sciences Center</name>
      <address>
        <city>Kochi</city>
        <zip>781-0111</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Takehiro Okabayashi, MD PhD</last_name>
      <phone>+81 88-837-3000</phone>
      <email>takehiro_okabayashi@khsc.or.jp</email>
    </contact>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>March 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kochi University</investigator_affiliation>
    <investigator_full_name>Takehiro Okabayashi</investigator_full_name>
    <investigator_title>Division Manager</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03021876
org study id: LAMP study
nct id: NCT03021876
lead sponsor: 
has dmc: Yes
L-carnitine is synthesized from lysine and methionine. Postmortem concentrations of carnitine
      in liver, muscle, heart, kidney, and brain averaged only one-fourth to one-third those in
      corresponding tissues of eight normally nourished non-hepatic patients who died after an
      acute illness of a 1-3-day duration. In the recent years, it has been reported that sirtuin 3
      (SIRT3) is protective against acute kidney injury (AKI) and suggest that enhancing SIRT3 to
      improve mitochondrial dynamics has potential as a strategy for improving outcomes of renal
      injury. In the current study, it is the first clinical interventional research whether
      L-carnitine corrects ammonia metabolism associated with liver injury in hepatectomized
      patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: postoperative ammonia levels
time frame: 3 points; preoperative baseline, postoperative day 1, and day3
description: change from preoperative baseline at postoperative day 1 and day3
measure: length of hospitalization after liver resection
time frame: up to 24 weeks
description: postoperative days
arm group label: ordinary group
arm group type: Placebo Comparator
description: usual intake prior to liver surgery
arm group label: carnitine group
arm group type: Active Comparator
description: treatment with oral L-carnitine, 1500 mg/body per day for 2 weeks prior to liver surgery
intervention type: Drug
intervention name: L-carnitine
description: treatment with oral L-carnitine, 1500 mg/body per day
arm group label: carnitine group
other name: Carnitine group
intervention type: Other
intervention name: usual intake
description: baseliner
arm group label: ordinary group
other name: Usual group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Takehiro Okabayashi, MD
phone: +81 88-837-3000
email: tokabaya@gmail.com
facility: 
status: Recruiting
contact: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Kochi University
investigator full name: Takehiro Okabayashi
investigator title: Division Manager
sharing ipd: No