UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038266
Receipt No. 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 2019/11/17

* 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 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
Email 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
Email akawashima@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

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
Email 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 No longer recruiting
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
2019 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.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


Contact us.