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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031423
Receipt No. 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

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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
Obsterics 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
Email 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
Email ginga.suzuki@med.toho-u.ac.jp

Sponsor
Institute Toho University Omori Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035882

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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