UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061895 |
|---|---|
| Receipt number | R000070822 |
| Scientific Title | Construction of an Input Data Structure for Biothermal Modeling Using Clinical, Exposure, and Environmental Data in Patients with Heatstroke: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/06/13 |
| Last modified on | 2026/06/13 14:49:31 |
* 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 Study to Evaluate Heat Stress Using Clinical, Exposure, and Environmental Data in Patients with Heatstroke
Acronym
SAFE-HEAT Study
Scientific Title
Construction of an Input Data Structure for Biothermal Modeling Using Clinical, Exposure, and Environmental Data in Patients with Heatstroke: A Prospective Observational Study
Scientific Title:Acronym
SAFE-HEAT Study
Region
| Japan |
Condition
Condition
Heat Stroke
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to construct an input data structure for connecting real-world clinical data to a biothermal model in adult patients who are transported to or visit the emergency department with heatstroke or heat-related illness.
Clinical, exposure, and environmental information required for biothermal modeling will be extracted from medical records, ambulance records, and public environmental databases corresponding to the time and location of heat exposure. The study will also evaluate the availability of model-input variables, linkage feasibility with environmental data, and the proportion of cases in which model-derived thermophysiological indices can be calculated. Exploratory analyses will assess the relationship between model-derived indices and measured body temperature and clinical course.
Basic objectives2
Others
Basic objectives -Others
To exploratorily evaluate the associations between model-derived thermophysiological indices, including estimated core body temperature, rate of core temperature increase, body heat storage, and sweating burden, and clinical variables such as measured body temperature on arrival, cooling intervention, hospital admission, ICU admission, length of hospital stay, and laboratory data obtained during routine clinical care.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility of constructing a core clinical, exposure, and environmental dataset required for biothermal model input
Specifically, the study will evaluate the proportion of cases in which information on time and location of heat exposure, exposure duration, activity, clothing, ambient temperature, humidity, wet-bulb globe temperature, wind speed, solar radiation, and other relevant variables can be extracted from medical records, ambulance records, and public environmental databases and integrated into a format suitable for biothermal model input.
Key secondary outcomes
Availability rate of each model-input variable
Linkage rate with environmental data based on the time and location of heat exposure
Proportion of cases in which model-derived indices, including estimated core body temperature, rate of core temperature increase, body heat storage, and sweating burden, can be calculated
Difference between model-estimated core body temperature and measured body temperature on arrival
Exploratory associations between model-derived thermophysiological indices and clinical course, including cooling intervention, hospital admission, ICU admission, and length of hospital stay
Exploratory associations between model-derived indices and laboratory data obtained during routine clinical care
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 18 years or older
Patients transported to or visiting the emergency department of Yamagata University Hospital
Patients diagnosed with heatstroke or heat-related illness
Patients for whom written informed consent is obtained from the patient or a legally acceptable representative
Key exclusion criteria
Patients in whom conditions other than heatstroke, such as infection, central nervous system disease, neuroleptic malignant syndrome, or acute drug intoxication, are clearly considered the primary cause of hyperthermia
Patients with insufficient information on the time or location of heat exposure, making acquisition of environmental data difficult
Patients with substantial missing data for key variables required for biothermal model input
Patients or legally acceptable representatives who decline participation or withdraw consent
Patients judged by the principal investigator to be inappropriate for inclusion in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryuto |
| Middle name | |
| Last name | Yokoyama |
Organization
Yamagata University
Division name
Department of Emergency Medicine, Yamagata University Faculty of Medicine
Zip code
990-9585
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
TEL
0236331122
ryusi0311@gmail.com
Public contact
Name of contact person
| 1st name | RYUTO |
| Middle name | |
| Last name | YOKOYAMA |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Emergency Medicine, Yamagata University Faculty of Medicine
Zip code
9909585
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
TEL
0236285422
Homepage URL
ryusi0311@gmail.com
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Funding Source
Organization
Yamagata Univercity
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
Ethics Review Committee, Faculty of Medicine, Yamagata University
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
Tel
0236331122
ryusi0311@gmail.com
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
| 2026 | Year | 06 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center, prospective, observational study of patients with heatstroke or heat-related illness who are transported to or visit the emergency department of Yamagata University Hospital. No research-specific intervention will be performed. The study will collect clinical information obtained during routine care, ambulance records, and public environmental data corresponding to the time and location of heat exposure.
The main exposure-related variables include time and location of heat exposure, exposure duration, indoor or outdoor setting, activity, clothing, air-conditioning use, fluid intake, ambient temperature, humidity, wet-bulb globe temperature, wind speed, and solar radiation. The main outcomes include feasibility of constructing a model-input dataset, availability rate of each input variable, linkage rate with environmental data, proportion of cases in which model-derived indices can be calculated, and exploratory associations between model-derived thermophysiological indices and clinical course.
Eligible patients who meet the inclusion criteria and do not meet any exclusion criteria will be consecutively enrolled during the study period.
Management information
Registered date
| 2026 | Year | 06 | Month | 13 | Day |
Last modified on
| 2026 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070822
