UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038266 |
|---|---|
| Receipt number | R000043620 |
| Scientific Title | A retrospective observational study of blood culture collection in patients with accidental hypothermia |
| Date of disclosure of the study information | 2019/10/11 |
| Last modified on | 2021/10/11 11:12:17 |
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Basic information
Public title
A retrospective observational study of blood culture collection in patients with accidental hypothermia
Acronym
Aroha study
Scientific Title
A retrospective observational study of blood culture collection in patients with accidental hypothermia
Scientific Title:Acronym
Aroha study
Region
| Japan |
Condition
Condition
Hypothermia
Classification by specialty
| Medicine in general | Infectious disease | Laboratory medicine |
| Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the significance of blood culture collection in patients with hypothermia and investigate factors related to treatment of hypothermia and prognosis.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood culture results and time, true blood culture positive rate, contamination rate
Key secondary outcomes
Patient background (including age, gender, primary disease), diagnosis, body temperature at first treatment, antibiotics, culture tests, blood counts / biochemical tests / coagulation tests / immunological tests, death and outcome
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited the National Center for Global Health and Medicine emergency department from January 1, 2012 to April 31, 2019 and received treatment for hypothermia.
Key exclusion criteria
Cases with missing values in the subject background information item
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tatsuki |
| Middle name | |
| Last name | Uemura |
Organization
National Center for Global Health and Medicine
Division name
Emergency department
Zip code
162-8655
Address
1-21-1, Toyama,Shinjuku-ku,Tokyo, Japan
TEL
03-3202-7181
tuemura@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Kawashima |
Organization
National Center for Global Health and Medicine
Division name
Emergency department
Zip code
162-8655
Address
1-21-1, Toyama,Shinjuku-ku,Tokyo, Japan
TEL
03-3202-7181
Homepage URL
akawashima@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
National Center for Global Health and Medicine
Address
1-21-1, Toyama,Shinjuku-ku,Tokyo, Japan
Tel
03-3202-7181
akawashima@hosp.ncgm.go.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
| 2019 | Year | 10 | Month | 11 | 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
200
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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is for adults over the age of 20.
Patients who visited our emergency department from January 1, 2012 to April 31, 2019 and received treatment for hypothermia.
Management information
Registered date
| 2019 | Year | 10 | Month | 10 | Day |
Last modified on
| 2021 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043620
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
