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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013866
Receipt No. R000013768
Scientific Title Predicting bacteremia based on nurse-assessed food consumption and shaking chill at the time of blood culture: prospective cohort study
Date of disclosure of the study information 2014/05/01
Last modified on 2015/05/08

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Basic information
Public title Predicting bacteremia based on nurse-assessed food consumption and shaking chill at the time of blood culture: prospective cohort study
Acronym Clinical prediction rules for bacteremia.
Scientific Title Predicting bacteremia based on nurse-assessed food consumption and shaking chill at the time of blood culture: prospective cohort study
Scientific Title:Acronym Clinical prediction rules for bacteremia.
Region
Japan

Condition
Condition Patients who underwent blood cultures.
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Although vital signs compose 3 of the 4 current criteria for the diagnosis of Systemic Inflammatory Response Syndrome (SIRS), they contribute little to the diagnosis of the cause, which can be inflammation or infection. We focused on nurse-assessed food consumption at the time of blood culture, and reported that bacteremia is an unlikely occurrence in hospitalized patients who maintain adequate food consumption at the time of blood culture (Komatsu et al JHM 2012). But the problems on this study were 1) retrospective analysis, 2) single center study. Therefor we hypothesized that quantitative variations in food consumption or shaking chill could accurately distinguish those patients with or without bacteremia in multiple hospitals.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Blood culture; positive
Key secondary outcomes C-reactive protein
White blood cell counts

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
15 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients with postitive blood culture.
Key exclusion criteria Patients with anorexia-inducing conditions, such as gastrointestinal disease and those who were receiving chemotherapy for malignancy, were excluded. We also excluded patients who were not allowed to eat a
regular diet.
Target sample size 580

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji INOUE
Organization Juntendo University Nerima Hospital
Division name Cardiology
Zip code
Address 3-1-10, Nerimaku Takanodai, Tokyo
TEL 03-5923-3111
Email inouelsbm@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kenji INO
Organization Juntendo University Nerima Hospita
Division name Cardiology
Zip code
Address 3-1-10, Nerimaku Takanodai, Tokyo
TEL 03-5923-3111
Homepage URL
Email inouelsbm@gmail.com

Sponsor
Institute Juntendo University Nerima Hospita
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
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 順天堂大学医学部附属練馬病院(東京都)、練馬総合病院(東京都)、大泉生協病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results For patients who undergo blood culture study,
1) if the patients have enough consumption of food, low possibility of bacteremia.

2) if the patients have shaking chill, high possibility of bacteremia.
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
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 04 Month 01 Day
Date analysis concluded
2015 Year 04 Month 30 Day

Other
Other related information For patients who undergo blood culture study,
1) if the patients have enough consumption of food, low possibility of bacteremia.

2) if the patients have shaking chill, high possibility of bacteremia.

The combination of these two findings could be effective to consider bacteremia.

Management information
Registered date
2014 Year 05 Month 01 Day
Last modified on
2015 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013768

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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