UMIN-CTR Clinical Trial

Basic information
Public title	Effects of enteral nutrition with high-protein in critically ill patients
Acronym	Effects of enteral nutrition with high-protein in critically ill patients
Scientific Title	Effects of enteral nutrition with high-protein in critically ill patients
Scientific Title:Acronym	Effects of enteral nutrition with high-protein in critically ill patients
Region	Japan

Condition
Condition	Ventilated patients in the intensive care units
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of effects of enteral nutrition with high-protein in critically ill patients with normal nutrition
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum prealbumin concentration 7,14,28 days after the beginning of the study
Key secondary outcomes	ventilator-free days,ICU length of stay,hospital length of stay, SOFA score, serum albumin, white blood cell count, lymphocyte count, CRP, total cholesterol, urea nitrogen, creatinine 7,14,28 days after the beginning of the study, total daily dose of insulin, total energy, and protein dose during enteral nutrition total amount of administration of blood products (albumin, globulin et al) complications(vomiting, diarrhea, kidney injury, ventilator-associated pneumonia)

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	Food
Interventions/Control_1	Peptamen Intense
Interventions/Control_2	Sanet N3
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	1)admission to the ICU 2)need for intubation and mechanical intubation 3)an expected duration of ventilation more than 6 days 4)unnecessary for a renal replacement therapy 5)patients with consent for included in the study
Key exclusion criteria	1)contraindication for enteral nutrient with high quantity of proteins 2)BMI more than 30, less than 18.5 3)denial of intensive care by a patients or a patient family 4)allergy to milk, soy, lactose 5)need for total parenteral nutrition 6)need for a renal replacement therapy 7)Patients judged as inappropriate to perform the present trial by the j the doctor
Target sample size	34

Research contact person
Last name of lead principal investigator	1st name Hibiki Middle name Last name Serizawa
Organization	Osaka Saiseikai Senri Hospital
Division name	Senri Critical Care Medical Center
Zip code	565-0862
Address	1-1-6,Tsumkumodai,Suita-city,Osaka-fu
TEL	06-6871-0121
Email	webmaster_senri@senri.saiseikai.or.jp

Public contact
1st name of contact person	1st name Hibiki Middle name Last name Serizawa
Organization	Osaka Saiseikai Senri Hospital
Division name	Senri Critical Care Medical Center
Zip code	565-0862
Address	1-1-6,Tsumkumodai,Suita-city,Osaka-fu
TEL	06-6871-0121
Homepage URL	http://www.senri.saiseikai.or.jp/hospital/department/trial/c_research/list.html
Email	webmaster_senri@senri.saiseikai.or.jp

Sponsor
Institute	Osaka Saiseikai Senri Hospital
Institute
Department

Funding Source
Organization	Osaka Saiseikai Senri Hospital
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	Osaka Saiseikai Senri Hospital institutional review board
Address	1-1-6,Tsumkumodai,Suita-city,Osaka-fu
Tel	06-6871-0121
Email	webmaster_senri@senri.saiseikai.or.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 04 Month 26 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	2019 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date	2019 Year 04 Month 27 Day
Last follow-up date	2020 Year 04 Month 30 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 04 Month 26 Day
Last modified on	2019 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041704