Tokyo, June 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061895) titled 'A Study to Evaluate Heat Stress Using Clinical, Exposure, and Environmental Data in Patients with Heatstroke' on June 13.
Study Type:
Observational
Primary Sponsor:
Institute - Yamagata University
Condition:
Condition - Heat Stroke
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 18
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 Size - 50
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070822
Disclaimer: Curated by HT Syndication.