UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054559 |
|---|---|
| Receipt number | R000062323 |
| Scientific Title | Branched-chain amino acids during acute phase for patients with hepatic encephalopathy: A systematic review and meta-analysis |
| Date of disclosure of the study information | 2024/06/04 |
| Last modified on | 2025/02/05 06:53:24 |
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Basic information
Public title
Branched-chain amino acids during acute phase for patients with hepatic encephalopathy: A systematic review and meta-analysis
Acronym
Branched-chain amino acids during acute phase for patients with hepatic encephalopathy: A systematic review and meta-analysis
Scientific Title
Branched-chain amino acids during acute phase for patients with hepatic encephalopathy: A systematic review and meta-analysis
Scientific Title:Acronym
Branched-chain amino acids during acute phase for patients with hepatic encephalopathy: A systematic review and meta-analysis
Region
| Japan |
Condition
Condition
hepatic encephalopathy
Classification by specialty
| Emergency medicine | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of administration of branched-chain amino acids (BCAAs) in patients with acute encephalopathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality
Key secondary outcomes
Improvement of disorientation, serious adverse events, nausea and diarrhea, and increased albumin
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Randomized controlled trials.
2) Adult patients with hepatic encephalopathy.
3) Comparison BCAA administration in emergency room and/or intensive care unit with placebo.
4) Japanese or English
Key exclusion criteria
Conference abstract
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Yatabe |
Organization
Nishichita General Hospital
Division name
Emergency department
Zip code
4778522
Address
3-1-1, Nakano-ike, Tokai, Aichi
TEL
0562335500
yatabe.tomoaki@katch.ne.jp
Public contact
Name of contact person
| 1st name | Tomoaki |
| Middle name | |
| Last name | Yatabe |
Organization
Nishichita General Hospital
Division name
Emergency department
Zip code
4778522
Address
3-1-1, Nakano-ike, Tokai, Aichi
TEL
0562335500
Homepage URL
yatabe.tomoaki@katch.ne.jp
Sponsor or person
Institute
Guideline committee of Japan Resuscitation Council (Neuroresuscitation)
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nishichita General Hospital
Address
3-1-1, Nakano-ike, Tokai, Aichi
Tel
0562335500
yatabe.tomoaki@katch.ne.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2024 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Database
We will use the PubMed, Cochrane Library databases, and ICHUSHI as database.
Data extraction
The abstracted data for each study included first author, year of publication, number of participating centers, number of patients, age, gender, cause of cirrhosis, Child classification, level of awareness and BCAA administration method.
Risk of bias assessment
We will assess risk of bias using RoB2.
Strategy for data synthesis
We will perform the meta-analysis (random effect) using RevMan software.
Management information
Registered date
| 2024 | Year | 06 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062323
