UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030376 |
|---|---|
| Receipt number | 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 | 2020/04/04 14:39:59 |
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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, 6. select the upper extremities for venipuncture site
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
| Not applicable |
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 | Kyohei |
| Middle name | |
| Last name | Kyohei Miyamoto |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN
TEL
073-441-0603
go.go.kyohei.miyamoto@gmail.com
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Kyohei Miyamoto |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
6410012
Address
811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN
TEL
073-441-0603
Homepage URL
go.go.kyohei.miyamoto@gmail.com
Sponsor or person
Institute
Wakayama Medical University, Department of Emergency and Critical Care Medicine
Institute
Department
Personal name
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
WMU IRB
Address
Wakayama
Tel
073-441-0603
gomadofu@wakayama-med.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
| 2017 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S1341321X20300830
Number of participants that the trial has enrolled
910
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
| 2017 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 30 | Day |
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
| 2020 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034680
