UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048856 |
|---|---|
| Receipt number | R000055671 |
| Scientific Title | A single center, non-randomized interventional study: Comparison of collecting blood cultures by a single venipuncture method and the double venipuncture method among critically ill patients in an ICU, Japan |
| Date of disclosure of the study information | 2022/09/05 |
| Last modified on | 2022/09/05 16:17:14 |
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Basic information
Public title
A single center, non-randomized interventional study: Comparison of collecting blood cultures by a single venipuncture method and the double venipuncture method among critically ill patients in an ICU, Japan
Acronym
Collecting method of blood cultures in ICU
Scientific Title
A single center, non-randomized interventional study: Comparison of collecting blood cultures by a single venipuncture method and the double venipuncture method among critically ill patients in an ICU, Japan
Scientific Title:Acronym
Collecting method of blood cultures in ICU
Region
| Japan |
Condition
Condition
all adult patients admitted to general ICU at a community hospital in Japan
Classification by specialty
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to verify the efficacy of simplifying methods of collecting blood cultures in the ICU setting
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
true incidence of positive blood cultures in the ICU setting
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
single venipuncture vs double venipuncture
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
all adult patients older than 18 year old admitted to general ICU
Key exclusion criteria
patients younger than 18 year old admitted to general ICU
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Makino |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Critical Care Medicine
Zip code
130-0075
Address
Kotobashi 4-23-15 Sumida-ku, Tokyo
TEL
03-3633-6151
junmakinony@gmail.com
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Makino |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Critical Care Medicine
Zip code
130-8575
Address
Kotobashi 4-23-15, Sumida-ku, Tokyo
TEL
03-3633-6151
Homepage URL
junmakinony@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Bokutoh Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Tokyo Metropolitan Bokutoh Hospital
Address
Kotobashi 4-23-15 Sumida-ku, Tokyo
Tel
03-3633-6151
junmakinony@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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 05 | 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
524
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
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 05 | Day |
Last modified on
| 2022 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055671
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
