UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030866 |
|---|---|
| Receipt number | 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 12:33:05 |
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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
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
shikatarawasagao@gmail.com
Sponsor or person
Institute
Hamamatsu medical center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035241
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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