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L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients

Sponsor
Kochi University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03021876
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
24
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients
Study Start Date :
Apr 1, 2016
Anticipated Primary Completion Date :
Apr 1, 2018
Anticipated Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: ordinary group

usual intake prior to liver surgery

Other: usual intake
baseliner
Other Names:
  • Usual group

    		•
    Active Comparator: carnitine group

    treatment with oral L-carnitine, 1500 mg/body per day for 2 weeks prior to liver surgery

    Drug: L-carnitine
    treatment with oral L-carnitine, 1500 mg/body per day
    Other Names:
  • Carnitine group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. postoperative ammonia levels [3 points; preoperative baseline, postoperative day 1, and day3]

      change from preoperative baseline at postoperative day 1 and day3

    Secondary Outcome Measures

    1. length of hospitalization after liver resection [up to 24 weeks]

      postoperative days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients were those surgically treated for hepato-biliary diseases
    Exclusion Criteria:
    • Patient exclusion criteria included a body weight loss greater than 10% during the six months prior to surgery, the presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kochi Health Sciences Center Kochi Japan 781-0111

    Sponsors and Collaborators

    • Kochi University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Takehiro Okabayashi, Division Manager, Kochi University
    ClinicalTrials.gov Identifier:
    NCT03021876
    Other Study ID Numbers:
    • LAMP study
    First Posted:
    Jan 16, 2017
    Last Update Posted:
    Jan 16, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Jan 16, 2017