UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052093 |
|---|---|
| Receipt number | R000056209 |
| Scientific Title | Metabolomics for analyzing acute energy metabolism in critically ill patients |
| Date of disclosure of the study information | 2023/09/03 |
| Last modified on | 2023/09/03 08:31:49 |
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Basic information
Public title
Metabolomics for analyzing acute energy metabolism in critically ill patients
Acronym
Metabolomics for analyzing acute energy metabolism in critically ill patients
Scientific Title
Metabolomics for analyzing acute energy metabolism in critically ill patients
Scientific Title:Acronym
Metabolomics for analyzing acute energy metabolism in critically ill patients
Region
| Japan |
Condition
Condition
Mechanically ventilated ICU patient, artificially fed
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the metabolic characteristic, especially regarding the balance between endogenous and exogenous energy consumption in ICU patients by revealing the evolution of metabolic pattern using metabolomics.
Basic objectives2
Others
Basic objectives -Others
To determine the metabolic characteristic, especially regarding the balance between endogenous and exogenous energy consumption in ICU patients by revealing the evolution of metabolic pattern using metabolomics.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the metabolome pattern in ICU patients
Key secondary outcomes
Relationship between Metabolome pattern and:
calorimetry, body composition, vital signs, laboratory data, nutrition
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Mechanically ventilated ICU patients with:
Age >20 year
Eligible for calorimetry
Key exclusion criteria
Age <20 years
highly invasive ventilation
uncontrolled diabetes
use of steroids and immune-suppresors
malignancy
pregnancy
others considered inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Taka-aki |
| Middle name | |
| Last name | Nakada |
Organization
Chiba University Graduate School of Medicine
Division name
Emergency and Critical Care Medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba
TEL
043-226-2341
takanakada0@gmail.com
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Oshima |
Organization
Chiba University Graduate School of Medicine
Division name
Emergency and Critical Care Medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba
TEL
043-226-2341
Homepage URL
t_oshima@chiba-u.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS Kakenhi
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee,Chiba University Graduate School of Medicine
Address
1-8-1 Inohana,Chuo-ku, Chiba City, Chiba
Tel
043-222-7171
igaku-rinri@office.chiba-u.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
| 2023 | Year | 09 | Month | 03 | 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
19
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 09 | Month | 03 | Day |
Last modified on
| 2023 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056209
