L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients

January 12, 2017 updated by: Takehiro Okabayashi, Kochi University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Kochi, Japan, 781-0111
        • Recruiting
        • Kochi Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative ammonia levels
Time Frame: 3 points; preoperative baseline, postoperative day 1, and day3
change from preoperative baseline at postoperative day 1 and day3
3 points; preoperative baseline, postoperative day 1, and day3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of hospitalization after liver resection
Time Frame: up to 24 weeks
postoperative days
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kochi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ANTICIPATED)

April 1, 2018

Study Completion (ANTICIPATED)

April 1, 2018

Study Registration Dates

First Submitted

March 12, 2016

First Submitted That Met QC Criteria

January 12, 2017

First Posted (ESTIMATE)

January 16, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • LAMP study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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