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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030866
Receipt No. R000035241
Scientific Title Efficacy and safety of high-protein early enteral nutrition in critically ill patients with respiratory failure, single-center prospective randomized control trial
Date of disclosure of the study information 2018/01/17
Last modified on 2020/07/20

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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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