UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of bacterial contamination in continuous administration of enteral nutrition in a semi-closed system
Title of the study (Brief title)	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	Junji HATAKEYAMA
Organization	Yokohama City Minato Red Cross Hospital
Division name	Department of Intensive Care Medicine
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	Junji HATAKEYAMA
Organization	Yokohama City Minato Red Cross Hospital
Division name	Department of Intensive Care Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000028770