UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021381 |
|---|---|
| Receipt number | R000024661 |
| Scientific Title | Utility of procalcitonin of the fever patient |
| Date of disclosure of the study information | 2016/03/14 |
| Last modified on | 2019/12/20 16:14:35 |
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Basic information
Public title
Utility of procalcitonin of the fever patient
Acronym
Effective inspection of procalcitonin
Scientific Title
Utility of procalcitonin of the fever patient
Scientific Title:Acronym
Effective inspection of procalcitonin
Region
| Japan |
Condition
Condition
retrospective study
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Seriousness classification of the fever patient with procalcitonin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cut-off line of the severity of the fever patient
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient that fever was received for main complaint by department of internal medicine.
Key exclusion criteria
pregnant
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Keigo |
| Middle name | |
| Last name | Ashitani |
Organization
Saitama medical university
Division name
general medicine
Zip code
350-0495
Address
saitama prefecture iruma gunn moroyamamati town morohonngou 38
TEL
049-276-1667
southern.cross.1207@gmail.com
Public contact
Name of contact person
| 1st name | Keigo |
| Middle name | |
| Last name | Ashitani |
Organization
Saitama medical university
Division name
general medicine
Zip code
350-0495
Address
saitama prefecture iruma gunn moroyamamati town morohonngou 38
TEL
049-276-1667
Homepage URL
southern.cross.1207@gmail.com
Sponsor or person
Institute
Saitama medical university general internal medicine
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University Hospital Hospital IRB
Address
saitama prefecture iruma gunn moroyamamati town morohonngou 38
Tel
049-276-1354
hirb@saitama-med.ac.jp
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
| 2016 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
http://www.saitama-med.ac.jp/hospital/outline/irb_kouhou.html
Publication of results
Published
Result
URL related to results and publications
http://www.saitama-med.ac.jp/hospital/outline/irb_kouhou.html
Number of participants that the trial has enrolled
200
Results
It was confirmed that the PCT showed a low to high-value disease-specifically.
Results date posted
| 2019 | Year | 12 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
hospitalized patient
Participant flow
hospitalized patient
Adverse events
none
Outcome measures
DIC score, various inflammatory reactions
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 31 | Day |
Other
Other related information
nothing
Management information
Registered date
| 2016 | Year | 03 | Month | 07 | Day |
Last modified on
| 2019 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024661
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
