UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059233 |
|---|---|
| Receipt number | R000067751 |
| Scientific Title | High-protein nutrition in ICU patients undergoing advanced early mobilization |
| Date of disclosure of the study information | 2025/09/29 |
| Last modified on | 2025/09/29 19:24:40 |
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Basic information
Public title
High-protein nutrition in ICU patients undergoing advanced early mobilization
Acronym
High-protein nutrition in ICU patients undergoing advanced early mobilization
Scientific Title
High-protein nutrition in ICU patients undergoing advanced early mobilization
Scientific Title:Acronym
High-protein nutrition in ICU patients undergoing advanced early mobilization
Region
| Japan |
Condition
Condition
ICU patients
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Clinical immunology |
| Infectious disease | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Endocrine surgery | Breast surgery | Obstetrics and Gynecology |
| Orthopedics | Anesthesiology | Neurosurgery |
| Cardiovascular surgery | Operative medicine | Emergency medicine |
| Blood transfusion | Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This trial aims to investigate whether combining high-protein nutrition with early mobilization can promote physical and functional recovery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the motor score of the Functional Independence Measure (FIM) at hospital discharge
Key secondary outcomes
At ICU discharge: Functional Status Score for the ICU (FSS-ICU) [27], Medical Research Council (MRC) score, and ICU length of stay.
At 14 days after ICU discharge: FIM motor, FIM cognitive (FIM cog), Mini-Mental State Examination (MMSE), body composition parameters, MRC score, and Brief Pain Inventory (BPI).
At hospital discharge: MRC score, FIM cog, body composition parameters, BPI, length of hospital stay, and mortality.
At 60 days after hospital discharge: FIM motor score, MRC score, FIM cog, MMSE score, body composition parameters, and BPI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
In the control group, nutritional administration is targeted at the lower limit of the protein level (1.2 g/kg/day) indicated in each guideline. The intervention group will be fed at 1.8 g/kg/day of protein.
Interventions/Control_2
In the control group, nutritional administration is targeted at the lower limit of the protein level (1.2 g/kg/day) indicated in each guideline. The intervention group will be fed at 1.8 g/kg/day of protein.
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
Inclusion criteria were (1) general or emergency (ICU) inpatients aged 18 years or older, (2) independent of ADLs prior to admission, and (3) patients expected to remain on a ventilator for at least 48 hours.
Key exclusion criteria
Exclusion criteria are (1) scheduled surgical patients, (2) patients weighing 200 kg or more (due to device weight capacity of up to 200 kg), (3) patients admitted for neuromuscular disease, (4) patients with leg loss or load limitation due to post-hospitalization surgery, (5) patients transferred after 48 hours of ventilation, (6) patients for whom enteral nutrition is impossible; and (7) patients expected to die within 7 days.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Ginga |
| Middle name | |
| Last name | Suzuki |
Organization
Toho University Omori Medical Center
Division name
Critical Care Center
Zip code
1438541
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
TEL
0337624151
ginga.suzuki@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Ginga |
| Middle name | |
| Last name | Suzuki |
Organization
Toho University Omori Medical Center
Division name
Critical Care Center
Zip code
1438541
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
TEL
0337624151
Homepage URL
ginga.suzuki@med.toho-u.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Ginga Suzuki
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
the Ethics Committee of Toho University School of Medicine
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
Tel
0337624151
med.rinri@ext.toho-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
| 2025 | Year | 09 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 29 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067751
