UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043295 |
|---|---|
| Receipt number | R000049436 |
| Scientific Title | Effect of early high protein nutrition in critically ill patients: A pilot randomized controlled trial |
| Date of disclosure of the study information | 2021/02/10 |
| Last modified on | 2021/02/10 14:59:05 |
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Basic information
Public title
Effect of early high protein nutrition in critically ill patients
Acronym
Early high protein nutrition in critically ill patients
Scientific Title
Effect of early high protein nutrition in critically ill patients: A pilot randomized controlled trial
Scientific Title:Acronym
Early 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 the effect of early high protein nutrition in patients receiving tube fed mechanical ventilated patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total amino acid concentration at a week
Key secondary outcomes
length of ICU stay, 28 day mortality, 90 day mortality
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
30
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
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
ginga.suzuki@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
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
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
| 2021 | Year | 02 | Month | 10 | 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
| 2021 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 10 | Day |
Last modified on
| 2021 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049436
