L-carnitine Corrects Ammonia Metabolism in Hepatectomized... | NCT03021876

Studies
L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients

NCT03021876

Sponsor

Kochi University

Status

Unknown status

Last Update Posted

Jan 16, 2017Estimated

Enrollment

80Estimated

Phase

Phase 2Phase 3

Conditions

Ammonia Metabolism

Interventions

L-carnitine
usual intake

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Apr 2018Estimated

Completion Date

Apr 2018Estimated

First Submitted Date

Mar 12, 2016

First Submission Date that Met QC Criteria

Jan 12, 2017

First Posted Date

Jan 16, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2017

Last Update Posted Date

Jan 16, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ordinary group	Placebo Comparator	usual intake prior to liver surgery	Other: usual intake
carnitine group	Active Comparator	treatment with oral L-carnitine, 1500 mg/body per day for 2 weeks prior to liver surgery	Drug: L-carnitine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
L-carnitine	Drug	treatment with oral L-carnitine, 1500 mg/body per day	carnitine group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Takehiro Okabayashi, MD	Contact	+81 88-837-3000		tokabaya@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kochi Health Sciences Center	Recruiting	Kochi	Kochi	781-0111	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31599019	Derived	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.

ID	Term
D050337	Trimethyl Ammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals