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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042614
Receipt No. R000048633
Scientific Title Rapid high-protein nutrition in critically ill patients: A pilot randomized controlled trial.
Date of disclosure of the study information 2020/12/01
Last modified on 2020/12/01

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Basic information
Public title Effect of high protein nutrition in critically ill patients
Acronym Effect of high protein nutrition
Scientific Title Rapid high-protein nutrition in critically ill patients: A pilot randomized controlled trial.
Scientific Title:Acronym Rapid high-protein nutrition in critically ill patients.
Region
Japan

Condition
Condition Diseases seen in ICU
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate whether ICU length of stay can be shortened by achieving the target protein dose within 24-48 hours.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ICU length of stay
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
Interventions/Control_1 Intervention group
Amino acid infusion and enteral nutrition are used in combination to achieve a protein dose of 1.5 g / kg / day (1.7 g / kg / day for patients undergoing renal replacement therapy) within 24-48 hours after admission.

Interventions/Control_2 Control group
Intestinal nutrition is started within 24-48 hours after admission, and a protein dose of 1.5 g / kg / day (1.7 g / kg / day for patients undergoing renal replacement therapy) is achieved within a week thereafter.
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 Patients expected to require ventilator management for 3 days or longer
Key exclusion criteria Patients who cannot use enteral nutrition or do not agree with the study
Target sample size 42

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 None
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 Toho University Omori Medical Center Ethics Committee
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
Tel 03-5763-6534
Email omori.rinri@ext.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
2020 Year 12 Month 01 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
2020 Year 11 Month 30 Day
Date of IRB
2017 Year 02 Month 22 Day
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2023 Year 11 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
2020 Year 12 Month 01 Day
Last modified on
2020 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048633

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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