UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046610 |
|---|---|
| Receipt number | R000053170 |
| Scientific Title | Randomized study of Enteral Nutrition with Rapid vs. conventional administration in acute stroke patients (Rapid EN trial) |
| Date of disclosure of the study information | 2022/01/16 |
| Last modified on | 2022/01/12 14:56:54 |
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Basic information
Public title
Randomized study of Enteral Nutrition
with Rapid vs. conventional administration
in acute stroke patients (Rapid EN trial)
Acronym
Rapid EN trial
Scientific Title
Randomized study of Enteral Nutrition
with Rapid vs. conventional administration
in acute stroke patients (Rapid EN trial)
Scientific Title:Acronym
Rapid EN trial
Region
| Japan |
Condition
Condition
Acute stroke
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety of enteral nutrition with rapid administration compared to conventional administration for patients with acute stroke within 7 days of onset who have difficulty eating.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of new pneumonia / diarrhea / vomiting within 7 days from enteral nutrition start (non-inferiority)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
1 to 3 day:
amount of enteral nutrition 100ml
speed 100ml/5min
4 to 7 day:
amount of enteral nutrition free
speed 100ml/5min
Interventions/Control_2
1 to 3 day:
amount of enteral nutrition 100ml
speed under 200ml/h
4 to 7 day:
amount of enteral nutrition free
speed under 200ml/h
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
1 Age over 18 years at the time of giving informed consent
2 Acute stroke patients within 7 days from onset.
3 Patients who can be randomized within 72 hours from informed consent.
4 Among patients without severe consciousness disorder with Japan coma scale 0 to 3, who have difficulty in oral intake with modified WST 1 to 3, and patients with severe consciousness disorder with Japan coma scale 10 to 300
5 Head up 30 degrees or more is possible
6 Written informed consent by patient or next of kin
Key exclusion criteria
1. Patients with gastrointestinal obstructive disease
2. Pregnancy or possibility of pregnancy
3. Unlikely to complete the study, such as due to progressive malignant tumor
4. Judged as incompatible for the study by the investigators
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Kazumi |
| Middle name | |
| Last name | Kimura |
Organization
Nippon medical school
Division name
Neurology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan
TEL
0338222131
kentarow@nms.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Suzuki |
Organization
Nippon medical school
Division name
Neurology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan
TEL
0338222131
Homepage URL
kentarow@nms.ac.jp
Sponsor or person
Institute
Nippon medical school
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical school center for clinical research
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan
Tel
0338222131
clinicaltrial@nms.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
| 2022 | Year | 01 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2022 | Year | 01 | Month | 12 | Day |
Last modified on
| 2022 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053170
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
