An interventional study of the early in-hospital temperature management protocol for heat stroke patients in Heat Stroke, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 7 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
Heat stroke is a life-threatening clinical syndrome characterized by an imbalance between heat production and heat dissipation in the body, resulting from exposure to hot and humid environments and/or strenuous exercise. It is defined by an elevated core temperature exceeding 40°C and central nervous system abnormalities, accompanied by multi-organ dysfunction. The severity of cellular and tissue damage in heat stroke patients depends on the peak temperature reached and the duration of hyperthermia. Rapid reduction of core temperature can halt cellular damage, quickly reverse organ dysfunction, and improve patient outcomes. Therefore, early identification and rapid cooling are crucial to prevent irreversible damage and death in heat stroke patients. However, there is a lack of systematic and specific protocols to guide emergency medical staff in the standardized and effective management of body temperature in heat stroke patients. To address this, our research team previously developed an early in-hospital temperature management protocol for heat stroke patients based on the best available evidence, expert consultations, and expert panel meetings. This study aims to validate the feasibility and effectiveness of the protocol through clinical research, providing a basis for clinical practice.
21 studies on the registry are indexed under Heat Stroke; 10 are open to participants now.
This study's planned enrollment of 188 is above the median of 34 across 13 interventional studies indexed under Heat Stroke.
Browse Heat Stroke studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
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Exclusion Criteria:
Using the early in-hospital temperature management protocol for heat stroke patients developed in our previous research, we will implement early identification, rapid cooling, and precise target temperature management for this group of patients.
Other: the early in-hospital temperature management protocol for heat stroke patients
We will retrospectively collect data on heat stroke patients who were visited before the implementation of the early in-hospital temperature management protocol between 2021 and 2022, meaning this group of patients received temperature management according to the original methods used by their respective hospitals.
The early in-hospital temperature management protocol for heat stroke includes early identification, selection of cooling methods for rapid cooling, precise target temperature management, and dynamic monitoring. Effective temperature management will be implemented for heat stroke patients to improve their outcomes.
cooling rate at 0.5 hours
The cooling rate at 0.5 hours was calculated in reference to initial body temperature and body temperature at 0.5 hours
Time frame: 0.5 hours
Body temperature at 0.5 hours
Body temperature at 0.5 hour refers to a reading obtained 25 to 35 minutes after admission.
Time frame: 0.5 hours
Body temperature at 2 hours
Body temperature at 2 hours refers to a reading taken 100 to 140 minutes after admission
Time frame: 2 hours
in-hospital mortality
Mortality from any cause during hospitalization
Time frame: 30 days
3-month mortality rate
death within 3 months after emergency visit
Time frame: 3 months
Number of participants with other complications
including heart failure, renal failure, coagulation disorders, respiratory failure, neurological sequelae, etc.
Time frame: 3 months
Started Jul 2024 (actual). Primary completion is estimated for Sep 2026, 26 months after the start.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →