UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025005 |
|---|---|
| Receipt number | 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 10:26:53 |
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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
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
s-hatakeyama.icu@yokohama.jrc.or.jp
Sponsor or person
Institute
Yokohama City Minato Red Cross Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028770
