UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031423 |
|---|---|
| Receipt number | R000035882 |
| Scientific Title | The effect of high-protein nutrition in the ICU patients. |
| Date of disclosure of the study information | 2018/02/23 |
| Last modified on | 2019/08/26 12:56:28 |
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Basic information
Public title
The effect of high-protein nutrition in the ICU patients.
Acronym
The effect of high-protein nutrition in the ICU.
Scientific Title
The effect of high-protein nutrition in the ICU patients.
Scientific Title:Acronym
The effect of high-protein nutrition in the ICU.
Region
| Japan |
Condition
Condition
sepsis,burn,trauma,hypothermia,hyperthermia,brain injury,herat failure,renal failure,pancreatitis
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Infectious disease | Surgery in general |
| Obstetrics and Gynecology | Orthopedics | Neurosurgery |
| Cardiovascular surgery | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey whether high-protein nutrition effects mortality and ICU free days.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mortality in 28 days
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
day1,peptamen INTENSE 10ml/h+amino acid infusion
day2,20ml/h+amino acid infusion
day3,30ml/h+amino acid infusion
...
Interventions/Control_2
day1,peptamen INTENSE 10ml/h
day2,20ml/h
day3,30ml/h
...
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
over 3 days ventilation and over 7 days starvation
Key exclusion criteria
maintainance dialysis,BMI<18,severe malnutrition
Target sample size
500
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 and Emergency Center
Zip code
143-8541
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 | Suzukii |
Organization
Toho University Omori Medical Center
Division name
Critical Care and Emergency Center
Zip code
143-8541
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
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University Omori Medical Center
Address
6-11-1,Omori-Nishi,Ota-ku,Tokyo,Japan
Tel
03
ginga.suzuki@med.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
| 2018 | Year | 02 | Month | 23 | 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
| 2018 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2018 | Year | 02 | Month | 22 | Day |
Last modified on
| 2019 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035882
