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A Study to Evaluate Heat Stress Using Clinical, Exposure, and Environmental Data in Patients with Heatstroke

Construction of an Input Data Structure for Biothermal Modeling Using Clinical, Exposure, and Environmental Data in Patients with Heatstroke: A Prospective Observational Study - SAFE-HEAT Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000061895
Enrollment
50
Registered
2026-06-13
Start date
2026-06-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heat Stroke

Interventions

None listed

Sponsors

Yamagata University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactRYUTO YOKOYAMA

Yamagata University Faculty of Medicine Department of Emergency Medicine, Yamagata University Faculty of Medicine

ryusi0311@gmail.com0236285422

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026