UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of high-protein early enteral nutrition in critically ill patients with respiratory failure, single-center prospective randomized control trial
Acronym	High-protein enteral nutrition in critically ill patients with respiratory failure
Scientific Title	Efficacy and safety of high-protein early enteral nutrition in critically ill patients with respiratory failure, single-center prospective randomized control trial
Scientific Title:Acronym	High-protein enteral nutrition in critically ill patients with respiratory failure
Region	Japan

Condition
Condition	critically ill patients requiring mechanical ventilation
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of high-protein early enteral nutrition
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	In-hospital mortality
Key secondary outcomes	Rate of combination parenteral nutrition Incidence rate of metabolic adverse effects Total insulin dosage Duration of ICU and hospital stay Duration of mechanical ventilation

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	High-protein enteral nutrition for 7 days (1.2 to 1.5 g/kg/day)
Interventions/Control_2	Standard enteral nutrition for 7 days (0.6 to 1.2 g/kg/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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Critically ill patients with respiratory failure initiating enteral nutrition within 48 hours after admission to intensive care unit
Key exclusion criteria	(1)Patients with unstable hemodynamics requiring repeated increase of noradrenaline dosage (2)Patients with chronic kidney disease not undergoing dialysis or not planning to undergo dialysis (3)Patients having problems (active gastrointestinal bleeding, ileus or short-bowel syndrome) for administration of enteral nutrition
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashi Ogasawara
Organization	Hamamatsu medical center
Division name	Department of respiratory medicine
Zip code
Address	328 Tomitsuka, Naka-ku, Hamamatsu, Shizuoka
TEL	0534537111
Email	shikatarawasagao@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Takashi Ogasawara
Organization	Hamamatsu medical center
Division name	Department of respiratory medicine
Zip code
Address	328 Tomitsuka, Naka-ku, Hamamatsu, Shizuoka
TEL	0534537111
Homepage URL
Email	shikatarawasagao@gmail.com

Sponsor
Institute	Hamamatsu medical center
Institute
Department

Funding Source
Organization	Hamamatsu medical center
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
Address
Tel
Email

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 01 Month 17 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	Completed
Date of protocol fixation	2018 Year 01 Month 15 Day
Date of IRB	2018 Year 01 Month 29 Day
Anticipated trial start date	2018 Year 01 Month 17 Day
Last follow-up date	2020 Year 07 Month 20 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 01 Month 17 Day
Last modified on	2020 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035241

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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