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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03021876
Other study ID # LAMP study
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received March 12, 2016
Last updated January 12, 2017
Start date April 2016
Est. completion date April 2018

Study information

Verified date January 2017
Source Kochi University
Contact Takehiro Okabayashi, MD
Phone +81 88-837-3000
Email tokabaya@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date April 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
L-carnitine
treatment with oral L-carnitine, 1500 mg/body per day
Other:
usual intake
baseliner

Locations

Country Name City State
Japan Kochi Health Sciences Center Kochi

Sponsors (1)

Lead Sponsor Collaborator
Kochi University

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative ammonia levels change from preoperative baseline at postoperative day 1 and day3 3 points; preoperative baseline, postoperative day 1, and day3
Secondary length of hospitalization after liver resection postoperative days up to 24 weeks