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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036025
Receipt No. R000040875
Scientific Title Applicability of in-hospital mortality prediction score for patients with hypothermia in a Japanese community hospital setting
Date of disclosure of the study information 2019/02/27
Last modified on 2019/02/27

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Basic information
Public title Applicability of in-hospital mortality prediction score for patients with hypothermia in a Japanese community hospital setting
Acronym Applicability of in-hospital mortality prediction score for patients with hypothermia
Scientific Title Applicability of in-hospital mortality prediction score for patients with hypothermia in a Japanese community hospital setting
Scientific Title:Acronym Applicability of in-hospital mortality prediction score for patients with hypothermia
Region
Japan

Condition
Condition hypothermia
Classification by specialty
Medicine in general Emergency medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to clarify the accuracy of in-hospital mortality prediction scores for patients with hypothermia in a Japanese community hospital setting.
Basic objectives2 Others
Basic objectives -Others accuracy of the in-hospital mortality prediction
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 30 day mortality after admission
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
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients aged 20 and more than 20 with principal diagnosis of hypothermia admitted to our hospital were included in the study.
Hypothermia was defined as core temperature less than 35 degrees Celsius, based on the definition by the International Classification of Diseases, Tenth Revision (ICD-10).
Key exclusion criteria Patients without data on age, blood pressure, pH, or creatinine level. Patients with any incidences of mental confusion.
Target sample size 39

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoto Ishimaru
Organization Akashi Medical Center
Division name Department of General Internal Medicine
Zip code
Address Akashi
TEL 0789361101
Email maru-tkb@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoto Ishimaru
Organization Akashi Medical Center
Division name Department of General Internal Medicine
Zip code
Address 743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
TEL 0789361101
Homepage URL
Email maru-tkb@umin.ac.jp

Sponsor
Institute Akashi Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2019 Year 02 Month 27 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
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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Using medical records from initial hospital visits, we retrospectively calculated in-hospital mortality prediction scores along with discriminative value for in-hospital mortality.
Severity of hypothermia was further defined as either mild (between 32 degrees Celsius and 35 degrees Celsius), moderate (28 degrees Celsius to 32 degrees Celsius) or severe (less than 28 degrees Celsius) following classifications used by Durrer et al.
Demographic data, the presence of bacteremia, blood pressure, pH, creatinine level and any incidences of mental confusion were obtained from patient's charts.

Management information
Registered date
2019 Year 02 Month 27 Day
Last modified on
2019 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040875

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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