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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025005
Receipt No. R000028770
Scientific Title A study of bacterial contamination in continuous administration of enteral nutrition in a semi-closed system
Date of disclosure of the study information 2016/11/28
Last modified on 2018/11/29

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Basic information
Public title A study of bacterial contamination in continuous administration of enteral nutrition in a semi-closed system
Acronym Bacterial contamination in continuous administration of enteral nutrition
Scientific Title A study of bacterial contamination in continuous administration of enteral nutrition in a semi-closed system
Scientific Title:Acronym Bacterial contamination in continuous administration of enteral nutrition
Region
Japan

Condition
Condition Critically ill patients who required continuous administration of enteral nutrition
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Document the occurrence of bacterial contamination in continuous administration of enteral nutrition in a semi-closed system
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Outcome of bacterial culture
Key secondary outcomes Stool score(King's stool chart), Gastric aspirate volume in 24 hours, pH in gastric fluid, Temperature enteral feeding product in 24 hours, Presence of gastroenteritis, Temperature and humidity in intensive care unit

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Receiving continuous administration of enteral nutrition in 24 hours
Interventions/Control_2
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 Meet following criteria
1. Adult critically ill patients
2. Receiving Continuous administration of enteral nutrition in a semi-closed system
Key exclusion criteria None
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji HATAKEYAMA
Organization Yokohama City Minato Red Cross Hospital
Division name Department of Intensive Care Medicine
Zip code
Address 3-12-1 Shin-yamashita, Naka-ku, Yokohama, 231-8682, Japan
TEL 045-628-6100
Email s-hatakeyama.icu@yokohama.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junji HATAKEYAMA
Organization Yokohama City Minato Red Cross Hospital
Division name Department of Intensive Care Medicine
Zip code
Address 3-12-1 Shin-yamashita, Naka-ku, Yokohama, 231-8682, Japan
TEL 045-628-6100
Homepage URL
Email s-hatakeyama.icu@yokohama.jrc.or.jp

Sponsor
Institute Yokohama City Minato Red Cross Hospital
Institute
Department

Funding Source
Organization Yokohama City Minato Red Cross Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 28 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
2016 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 26 Day
Last modified on
2018 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028770

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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