UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034797 |
|---|---|
| Receipt number | R000039686 |
| Scientific Title | The diagnostic accuracy of biomarkers for the prediction of sepsis and bacteremia in patients with suspected infection: a prospective observational study |
| Date of disclosure of the study information | 2018/11/12 |
| Last modified on | 2020/01/08 14:44:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The diagnostic accuracy of biomarkers for the prediction of sepsis and bacteremia in patients with suspected infection: a prospective observational study
Acronym
Early diagnosis of sepsis and bacteremia
Scientific Title
The diagnostic accuracy of biomarkers for the prediction of sepsis and bacteremia in patients with suspected infection: a prospective observational study
Scientific Title:Acronym
Early diagnosis of sepsis and bacteremia
Region
| Japan |
Condition
Condition
Suspected infectious disease
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the diagnostic accuracy of biomarkers for prediction of sepsis and bacteremia in patients with suspected infectious diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Result of blood culture
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients had been hospitalized at the Kawasaki Medical School Hospital Advanced Critical Care Center and who had undergone blood culture collection due to suspected infectious disease upon admission or during hospitalization.
Key exclusion criteria
Only patients who had undergone follow-up blood culture to confirm blood culture negativity were excluded.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shiino |
| Middle name | |
| Last name | Yasukazu |
Organization
Kawasaki Medical School
Division name
Department of Acute Medicine
Zip code
7010192
Address
577, Matsushima, Kurashiki-shi, Okayama, 701-0192, JAPAN
TEL
086-462-1111
shiino@me.com
Public contact
Name of contact person
| 1st name | Yasukazu |
| Middle name | |
| Last name | Shiino |
Organization
Kawasaki Medical School
Division name
Department of Acute Medicine
Zip code
7010192
Address
577, Matsushima, Kurashiki-shi, Okayama, 701-0192, JAPAN
TEL
086-462-1111
Homepage URL
shiino@me.com
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School
Address
577, Matsushima, Kurashiki-shi, Okayama, 701-0192, JAPAN
Tel
086-464-1076
kmsrec@med.kawasaki-m.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
| 2018 | Year | 11 | Month | 12 | Day |
Related information
URL releasing protocol
https://m.kawasaki-m.ac.jp/kenkyu/rinri/document/kadai/2018/1926-2.pdf
Publication of results
Published
Result
URL related to results and publications
http://igakkai.kms-igakkai.com/wp/wp-content/uploads/2019en/KMJ-E201945027.pdf
Number of participants that the trial has enrolled
210
Results
Presepsis and Procalcitonin demonstrated good predictive ability for bacteremia in patients suspected of infection. Using the cut-off values determined in our analysis, we achieved a clinically useful NPV. PSEP and PCT may be useful for ruling out bacteremia.
Results date posted
| 2020 | Year | 01 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Our study comprised patients who had been hospitalized in the Advanced Critical Care Center at Kawasaki Medical School Hospital in Okayama, Japan, from December 2014 through September 2016 and had been performed blood cultures due to suspected bacteremia upon admission or during hospitalization. Only patients who had a negative follow-up blood culture were excluded.
Participant flow
Observational study
Adverse events
none
Outcome measures
Blood culture result, Preseason, Procalcitonin, CRP, Blood test, Vital signs.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Basic information of each patients(Age, Gender, comorbidity), vital signs, result of routine blood test, Presepsin , Procalcitonin, result of blood culture, result of Real-time PCR of blood, suspected site of infection, qSOFA in ER.
Management information
Registered date
| 2018 | Year | 11 | Month | 07 | Day |
Last modified on
| 2020 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039686
