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Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000048856
Receipt No. 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

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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
Email 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
Email junmakinony@gmail.com

Sponsor
Institute Tokyo Metropolitan Bokutoh Hospital
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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