UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010630 |
|---|---|
| Receipt number | R000012429 |
| Scientific Title | Enforcement of care bundles for eradication of central venous catheter related blood steam infection and its education plan. |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2020/05/15 16:54:34 |
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Basic information
Public title
Enforcement of care bundles for eradication of central venous catheter related blood steam infection and its education plan.
Acronym
Enforcement of care bundles for eradication of central venous catheter related blood steam infection
Scientific Title
Enforcement of care bundles for eradication of central venous catheter related blood steam infection and its education plan.
Scientific Title:Acronym
Enforcement of care bundles for eradication of central venous catheter related blood steam infection
Region
| Japan |
Condition
Condition
Patietns with central venous catheters
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Large-scale survey for the actual situation of central venous catheter-related bloodstream infection in our country has not been made. Moreover, educational activities to spread the prevention of catheter-related bloodstream infection have not yet progressed. Therefore, in order to eradicate catheter-related bloodstream infections in intensive care units and zero mortality associated with bloodstream infection, to establish the education activities of bloodstream infection prevention measures for health care workers is the purpose of this study. Consequently, we expect the results of this study will be the cornerstone of multi-institutes' survey.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
By the intervention of thorough preventive measures, reduction of total days of catheter insertion and the reduction of catheter-related bloodstream infection rate is expected.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with central venous catheters in the intensive care unit
Key exclusion criteria
None
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Yorozu |
Organization
Kyorin University School of Medicine
Division name
Department of Anesthesiology
Zip code
181-8611
Address
MItaka City
TEL
0422475511
tyorozu@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Yorozu |
Organization
Kyorin Universiy, School of Medicine
Division name
Department of Anesthesiology
Zip code
181-8611
Address
MItaka City
TEL
0422475511
Homepage URL
tyorozu@gmail.com
Sponsor or person
Institute
Dept. of Anesthesiology, Kyorin University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science, Grants-in-Aid for Scientic Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyorin University, School of medicine
Address
MItaka City
Tel
0422475511
tyorozu@gmail.com
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
杏林大学医学部付属病院集中治療室（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data which might to be related to central venous catheter related blood stream infection and patients background are recorded into the data sheets by a medical staff who does not know the objective of this study.
Management information
Registered date
| 2013 | Year | 05 | Month | 01 | Day |
Last modified on
| 2020 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012429
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
