L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
January 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedJanuary 16, 2017
January 1, 2017
2 years
March 12, 2016
January 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative ammonia levels
change from preoperative baseline at postoperative day 1 and day3
3 points; preoperative baseline, postoperative day 1, and day3
Secondary Outcomes (1)
length of hospitalization after liver resection
up to 24 weeks
Study Arms (2)
ordinary group
PLACEBO COMPARATORusual intake prior to liver surgery
carnitine group
ACTIVE COMPARATORtreatment with oral L-carnitine, 1500 mg/body per day for 2 weeks prior to liver surgery
Interventions
treatment with oral L-carnitine, 1500 mg/body per day
Eligibility Criteria
You may qualify if:
- patients were those surgically treated for hepato-biliary diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kochi Universitylead
Study Sites (1)
Kochi Health Sciences Center
Kochi, Kochi, 781-0111, Japan
Related Publications (1)
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.
PMID: 31599019DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division Manager
Study Record Dates
First Submitted
March 12, 2016
First Posted
January 16, 2017
Study Start
April 1, 2016
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
January 16, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share