UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046314 |
|---|---|
| Receipt number | R000052853 |
| Scientific Title | A prospective study to evaluate the utility of phase angle in patients with cirrhosis |
| Date of disclosure of the study information | 2021/12/08 |
| Last modified on | 2021/12/08 02:32:10 |
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Basic information
Public title
A prospective study to evaluate the utility of phase angle in patients with cirrhosis
Acronym
A prospective study to evaluate the utility of phase angle in patients with cirrhosis
Scientific Title
A prospective study to evaluate the utility of phase angle in patients with cirrhosis
Scientific Title:Acronym
A prospective study to evaluate the utility of phase angle in patients with cirrhosis
Region
| Japan |
Condition
Condition
Liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The utility of phase angle in patients with cirrhosis
Basic objectives2
Others
Basic objectives -Others
The relationship between phase angle and malnutrition, sarcopenia, frailty, and covert hepatic encephalopathy
The relationship between phase angle and treatment of ascites
The relationship between phase angle and outcomes (overt hepatic encephalopathy, liver failure, and mortality)
The relationship between phase angle and BCAA
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between phase angle and malnutrition, sarcopenia, frailty, and covert hepatic encephalopathy
Key secondary outcomes
The relationship between phase angle and treatment of ascites
The relationship between phase angle and outcomes (overt hepatic encephalopathy, liver failure, and mortality)
The relationship between phase angle and BCAA
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with cirrhosis aged 20 or more
2.Written informed consent
Key exclusion criteria
1.Patients with extrahepatic malignancies
2.Patients with severe comorbidities such as heart, renal, and respiratory failure
3.Patients who are inadequate for the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tatsunori |
| Middle name | |
| Last name | Hanai |
Organization
Gifu University Hospital
Division name
Center for Nutrition Support & Infection Control
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6308
hanai@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Miwa |
Organization
Gifu University Hospital
Division name
The First Department of Internal Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6308
Homepage URL
miwa_t@gifu-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology/Internal medicine, Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board of the Gifu University Graduate School of Medicine
Address
1-1 Yanagido, Gifu, Japan
Tel
058-230-6059
rinri@gifu-u.ac.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
| 2021 | Year | 12 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational study aimed to evaluate the utility of phase angle in patients with cirrhosis.
Management information
Registered date
| 2021 | Year | 12 | Month | 08 | Day |
Last modified on
| 2021 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052853
