UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013866 |
|---|---|
| Receipt number | 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 04:55:54 |
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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
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
inouelsbm@gmail.com
Sponsor or person
Institute
Juntendo University Nerima Hospita
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013768
