L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients

NCT ID: NCT03021876

Last Updated: 2017-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ammonia Metabolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ordinary group

usual intake prior to liver surgery

Group Type PLACEBO_COMPARATOR

usual intake

Intervention Type OTHER

baseliner

carnitine group

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

Group Type ACTIVE_COMPARATOR

L-carnitine

Intervention Type DRUG

treatment with oral L-carnitine, 1500 mg/body per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

L-carnitine

treatment with oral L-carnitine, 1500 mg/body per day

Intervention Type DRUG

usual intake

baseliner

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Carnitine group Usual group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients were those surgically treated for hepato-biliary diseases
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kochi University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Takehiro Okabayashi

Division Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kochi Health Sciences Center

Kochi, Kochi, Japan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Japan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Takehiro Okabayashi, MD

Role: CONTACT

+81 88-837-3000

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Takehiro Okabayashi, MD PhD

Role: primary

+81 88-837-3000

References

Explore related publications, articles, or registry entries linked to this study.

Okabayashi T, Sui K, Mastumoto T, Iwata J, Morita S, Iiyama T, Shimada Y. l-Carnitine Improves Postoperative Liver Function in Hepatectomized Patients. JPEN J Parenter Enteral Nutr. 2020 Jul;44(5):823-830. doi: 10.1002/jpen.1720. Epub 2019 Oct 9.

Reference Type DERIVED
PMID: 31599019 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LAMP study

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.