UMIN-CTR Clinical Trial

Basic information
Public title	The effect of high-protein nutrition in the ICU patients.
Acronym	The effect of high-protein nutrition in the ICU patients.
Scientific Title	The effect of high-protein nutrition in the ICU patients.
Scientific Title:Acronym	The effect of high-protein nutrition in the ICU patients.
Region	Japan

Condition
Condition	sepsis,burn,trauma,hypothermia,hyperthermia,brain injury,herat failure,renal failure,pancreatitis,surgical
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 Geriatrics Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery Endocrine surgery Breast surgery Obsterics and gynecology Oto-rhino-laryngology Orthopedics Urology 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 in infection in the ICU.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Infection rate in the ICU.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Food
Interventions/Control_1	From the first day of nutrition initiation, continuous administration of 10-20 ml / h of peptamintense as tube feeding In combination, the infusion of amipalene 400ml ~ 1000ml body weight adjustment
Interventions/Control_2	From the first day of nutrition initiation, continuous administration of 10-20 ml / h of peptamintense as tube feeding Increase the volume by 10 ml / h every day.
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	104

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	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 Suzuki
Organization	Toho University Omori Medical Center
Division name	Critical Care 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	0337624151
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	2019 Year 06 Month 16 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	2019 Year 06 Month 15 Day
Date of IRB	2018 Year 02 Month 22 Day
Anticipated trial start date	2019 Year 06 Month 16 Day
Last follow-up date	2022 Year 06 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 16 Day
Last modified on	2019 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042251