UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056503 |
|---|---|
| Receipt number | R000064571 |
| Scientific Title | Survey study on early weaning rehabilitation and nutritional management in intensive care units |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2025/11/12 23:13:06 |
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Basic information
Public title
Survey study on early weaning rehabilitation and nutritional management in intensive care units
Acronym
Survey study on early weaning rehabilitation and nutritional management in intensive care units
Scientific Title
Survey study on early weaning rehabilitation and nutritional management in intensive care units
Scientific Title:Acronym
Survey study on early weaning rehabilitation and nutritional management in intensive care units
Region
| Japan |
Condition
Condition
Patients admitted to the intensive care unit with a rehabilitation plan in place within 48 hours
Classification by specialty
| Intensive care medicine | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the intensive care unit (ICU), many patients are critically ill with highly invasive surgeries, infections, and shock. For the early recovery and social reintegration of such patients, it is essential not only to cure the disease but also to prevent the loss of physical strength due to prolonged hospitalization. For this reason, early intervention in rehabilitation and nutritional management have become important, and since R4, an additional fee for early bed release rehabilitation and an additional fee for early nutritional intervention and management have been newly established in ICUs. Our hospital started early rehabilitation in R6, but data on the degree of exhaustion for each disease (surgery) have not been well reported.
Therefore, this study will clarify the characteristics and validity of the diseases and assessment methods by simultaneously conducting physical measurements such as impedance anthropometry, etc., and body weight and lower leg circumference measurements. These results will be useful for new rehabilitation therapy, supplementation, and nutritional management.
Basic objectives2
Others
Basic objectives -Others
Impedance anthropometry, vascular function tests, and measurements of thigh diameter, lower leg diameter, and other physical indicators will be taken at entry and at exit. Changes before and after entry and exit will be analyzed. In addition, the data will be compared by patient background and reason for admission (surgery, disease, etc.). From blood samples, we will correlate changes in total cholesterol, total protein, albumin, oxidative stress test (d-ROMS), and amino acids (outsourced j-test) with the impedance body composition analyzer.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Length of ICU stay, from admission to discharge
Key secondary outcomes
Muscle mass at ICU discharge, degree of improvement in gait, etc. at discharge
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
| Not applicable |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients admitted to the intensive care unit with a rehabilitation plan in place within 48 hours
Key exclusion criteria
Under 16 years old
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | NOBUYUKI |
| Middle name | |
| Last name | MASAKI |
Organization
National Defense Medical College
Division name
Intensive Care Medicine
Zip code
359-8513
Address
3-2,Namiki, Tokorozawa, Saitama, Japan
TEL
04-2995-1511
masakinobuyuki@hotmail.com
Public contact
Name of contact person
| 1st name | NOBUYUKI |
| Middle name | |
| Last name | MASAKI |
Organization
National Defense Medical College
Division name
Intensive Care Medicine
Zip code
359-8513
Address
3-2,Namiki, Tokorozawa, Saitama, Japan
TEL
04-2995-1511
Homepage URL
masakinobuyuki@hotmail.com
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
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
National Defense Medical Collge
Address
3-2,Namiki, Tokorozawa, Saitama, Japan
Tel
04-2995-1511
masaknobuyuki@hotmail.com
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
| 2025 | Year | 01 | Month | 01 | 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
| 2024 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Although this is a prospective study, there is no therapeutic intervention. The study is based on physical measurements within the scope of insurance coverage, and testing using residual specimens. The information collected will be analyzed at a later date. Since this is research for academic research purposes conducted by an academic research institution and falls under Article 8-1(2)(a)(d) of the Guidelines for Life and Medical Sciences, we will guarantee the opportunity to refuse participation in the research by opting out.
Management information
Registered date
| 2024 | Year | 12 | Month | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064571
