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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030376
Receipt No. R000034680
Scientific Title The implementation of bundle approach for reducing contamination rate of blood culture: prospective before-after study
Date of disclosure of the study information 2017/12/20
Last modified on 2018/11/07

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Basic information
Public title The implementation of bundle approach for reducing contamination rate of blood culture: prospective before-after study
Acronym The implementation of bundle approach for reducing contamination rate of blood culture
Scientific Title The implementation of bundle approach for reducing contamination rate of blood culture: prospective before-after study
Scientific Title:Acronym The implementation of bundle approach for reducing contamination rate of blood culture
Region
Japan

Condition
Condition Patients obtained blood culture in emergency department
Classification by specialty
Infectious disease Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effect of bundle approach for reducing the contamination rate of blood culture.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time course of contamination rate of blood culture
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Implementing the bundle approach for obtaining blood culture. This bundle includes following; 1. hand hygiene, 2. scrubbing by alcohol cotton, 3. skin disinfection by 1% clorhexidine alcohol, 4. use of sterile glove, 5. use of sterile cover-cloth
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 The patients obtained blood culture in emergency department
Key exclusion criteria The patients obtained only one set of blood culture.
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyohei Miyamoto
Organization Wakayama Medical University
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN
TEL 073-441-0603
Email go.go.kyohei.miyamoto@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kyohei Miyamoto
Organization Wakayama Medical University
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN
TEL 073-441-0603
Homepage URL
Email go.go.kyohei.miyamoto@gmail.com

Sponsor
Institute Wakayama Medical University, Department of Emergency and Critical Care Medicine
Institute
Department

Funding Source
Organization Wakayama Medical University, Department of Emergency and Critical Care Medicine
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 12 Month 20 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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 01 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
2017 Year 12 Month 13 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034680

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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