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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046610
Receipt No. 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

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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
Email 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
Email kentarow@nms.ac.jp

Sponsor
Institute Nippon medical school
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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