UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042057 |
|---|---|
| Receipt number | R000046924 |
| Scientific Title | Influence of balance of protein and non-protein calorie on physical prognosis in ICU patients |
| Date of disclosure of the study information | 2020/10/28 |
| Last modified on | 2022/09/29 21:24:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Influence of balance of protein and non-protein calorie on physical prognosis in ICU patients
Acronym
Influence of balance of protein and non-protein calorie on physical prognosis in ICU patients
Scientific Title
Influence of balance of protein and non-protein calorie on physical prognosis in ICU patients
Scientific Title:Acronym
Influence of balance of protein and non-protein calorie on physical prognosis in ICU patients
Region
| Japan |
Condition
Condition
Patients who need to ICU stay for more than 3 days.
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the relationship between the balance of protein and non-protein calories from ICU admission to hospital discharge and physical prognosis.
Basic objectives2
Others
Basic objectives -Others
To estimate the optimal balance of protein and calorie in ICU patients and optimal nutritional therapy after ICU stay.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Protein/non-protein calorie ratio from ICU admission to the day before hospital discharge.
Key secondary outcomes
1. Hospital outcome.
2. Barthel Index the day before hospital discharge.
3. Muscle mass the day before hospital discharge.
4. Relationship between pain level and muscle mass during hospitalization
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who need to stay the ICU for more than 3 days
Key exclusion criteria
1. Patients who died in hospital stay
2. Patients who refuse to participate in the study
3. Patients who had a stroke during the study period
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Katsumata |
Organization
Kochi Medical School
Division name
Department of Anesthesiology and intensive care medicine
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL
088-880-2471
katsu1206@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Katsumata |
Organization
Kochi Medical School
Division name
Department of Anesthesiology and intensive care medicine
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL
088-880-2471
Homepage URL
katsu1206@kochi-ac.jp
Sponsor or person
Institute
Department of Anesthesiology and intensive care medicine, Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
(Grants-in-aid for scientific research)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Kochi Medical School
Address
Kohasu, Oko-cho, Nankoku, Kochi,, Japan
Tel
088-880-2180
is21@kochi-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
高知大学医学部附属病院（高知県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collection
1) Age, height, weight
2) Reason of ICU admission
3) Outcome at ICU/hospital discharge
4) Pre-hospital ADL, comorbidities
5) APACHEII and SOFA score at ICU admission
6) Initiation of rehabilitation and nutritional therapy
7) Use of muscle relaxant and dialysis
8) Calorie and protein intake from ICU admission to the day before hospital discharge
9) Barthel Index and thickness of muscle (ICU admission, ICU discharge, day before hospital discharge)
10) Pain level during hospitalization (NRS, CPOT)
Management information
Registered date
| 2020 | Year | 10 | Month | 08 | Day |
Last modified on
| 2022 | 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=R000046924
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
