UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006709
Receipt number R000007901
Scientific Title accidental hypothermia in Miyagi prefecture: the Tohoku Earthquake
Date of disclosure of the study information 2011/11/11
Last modified on 2013/08/10 11:27:35

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Basic information

Public title

accidental hypothermia in Miyagi prefecture: the Tohoku Earthquake

Acronym

accidental hypothermia in Miyagi prefecture: the Tohoku Earthquake

Scientific Title

accidental hypothermia in Miyagi prefecture: the Tohoku Earthquake

Scientific Title:Acronym

accidental hypothermia in Miyagi prefecture: the Tohoku Earthquake

Region

Japan


Condition

Condition

accidental hypothermia

Classification by specialty

Emergency medicine Intensive care medicine Adult
Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study was to identify the characteristics of patients treated for accidental hypothermia documented after the Great East Japan Earthquake.

Basic objectives2

Others

Basic objectives -Others

epidemiology

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the number of accidental hypothermia and the prognosis

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 who visited the 72 emergency medical institutions in MIYAGI PREFECTURE within 72 hours post-quake with a body temperature of LESS THAN 36C UPON ARRIVAL and subsequently hospitalized were surveyed.

Key exclusion criteria

nothing

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hajime Furukawa

Organization

Tohoku University Hospital

Division name

Emergency center

Zip code


Address

1-1,Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan

TEL

81-22-717-7489

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hajime Furukawa

Organization

Tohoku University Hospital

Division name

Emergency Center

Zip code


Address


TEL

022-717-7489

Homepage URL


Email



Sponsor or person

Institute

Emergency Center of Tohoku University Hospital

Institute

Department

Personal name



Funding Source

Organization

Emergency Center of Tohoku University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2011 Year 11 Month 11 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

A total of 91 inpatients were identified at 13 institutions.
Seventy-three percent of hypothermic patients were tsunami victims. Sixty-six patients visited the hospital within 24 hours of the earthquake.
Many patients were successfully treated despite of the post-quake disruption of regional social infrastructure.

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

2011 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry

2012 Year 05 Month 01 Day

Date trial data considered complete

2012 Year 06 Month 01 Day

Date analysis concluded

2012 Year 07 Month 01 Day


Other

Other related information

This study is epidemiology of accidental hypothermia in Miyagi Prefecture after The Great East Japan earthquake.


Management information

Registered date

2011 Year 11 Month 11 Day

Last modified on

2013 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007901


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name