L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients

Kochi University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Ammonia Metabolism

Treatments: Other: usual intake; Drug: L-carnitine

Study type: Interventional

Funder types: Other

Identifiers

NCT03021876

LAMP study

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

ordinary group

Placebo Comparator group

Description:

usual intake prior to liver surgery

Treatment:

Other: usual intake

carnitine group

Active Comparator group

Description:

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

Treatment:

Drug: L-carnitine