UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009552 |
|---|---|
| Receipt number | R000011209 |
| Scientific Title | The tolerability study of oligomeric formula for early enteral nutrition in critically ill patients |
| Date of disclosure of the study information | 2012/12/15 |
| Last modified on | 2014/05/17 15:44:19 |
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Basic information
Public title
The tolerability study of oligomeric formula for early enteral nutrition in critically ill patients
Acronym
The tolerability study of oligomeric formula
Scientific Title
The tolerability study of oligomeric formula for early enteral nutrition in critically ill patients
Scientific Title:Acronym
The tolerability study of oligomeric formula
Region
| Japan |
Condition
Condition
Critically ill patients
Classification by specialty
| Pneumology | Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the tolerability and efficacy of oligomeric formula administered to critically ill patients in intensive care unit.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intolerability during enteral nutrition
diarrhea, vomiting/gastroesophageal reflux, residual gastric volume, feeling of fullness in the abdomen
Key secondary outcomes
nutrition status
laboratory evidence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
| Food |
Interventions/Control_1
Oligomeric formula
Interventions/Control_2
Polymeric formula
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
Critically ill patients initiating enteral nutrition within 48 hour after admission to intensive care unit
Key exclusion criteria
1. Severe intolerability for enteral nutrition or formula.
2. Patients having problem for administration of enteral nutrition.
3. Patients having problem to evaluate the intolerability due to complicated diseases during the study.
4. Patients judged as inadequate case by physician.
Target sample size
24
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, Hamamatsu, Shizuoka
TEL
053-453-7111
shikatarawasagao@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Ogasawarara |
Organization
Hamamatsu medical center
Division name
Department of respiratory medicine
Zip code
Address
328 Tomitsuka Hamamatsu
TEL
0534537111
Homepage URL
shikatarawasagao@gmail.com
Sponsor or person
Institute
Department of Respiratory Medicine, Hamamatsu Medical Center
Institute
Department
Personal name
Funding Source
Organization
Non
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
| 2012 | Year | 12 | Month | 15 | 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
| 2012 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 17 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 17 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 17 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 14 | Day |
Last modified on
| 2014 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011209
