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Application of an Early In-Hospital Temperature Management Protocol for Heat Stroke Patients

Application of an Early In-Hospital Temperature Management Protocol for Heat Stroke Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06537557
Enrollment
188
Registered
2024-08-05
Start date
2024-07-01
Completion date
2026-12-30
Last updated
2026-05-27

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

Conditions

Heat Stroke

Brief summary

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.

Interventions

OTHERthe early in-hospital temperature management protocol for heat stroke patients

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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER
Jinhua Municipal Central Hospital
CollaboratorOTHER
Yiwu Central Hospital
CollaboratorOTHER
Dongyang People's Hospital
CollaboratorOTHER
Jinhua People's Hospital
CollaboratorOTHER
Lanxi People's Hospital
CollaboratorOTHER
Yongkang No.1 People' s Hospital
CollaboratorUNKNOWN

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients admitted to the emergency department and diagnosed with heat stroke according to the China expert consensus on Heat Stroke

Exclusion criteria

* transferred from another hospital and body temperature \< 39.5℃; discharged within 4 hours, and subsequent body temperature or outcomes were unavailable; required immediate cardiopulmonary resuscitation; had other serious diseases, such as massive cerebral haemorrhage or severe trauma.

Design outcomes

Primary

MeasureTime frameDescription
cooling rate at 0.5 hours0.5 hoursThe cooling rate at 0.5 hours was calculated in reference to initial body temperature and body temperature at 0.5 hours
Body temperature at 0.5 hours0.5 hoursBody temperature at 0.5 hour refers to a reading obtained 25 to 35 minutes after admission.

Secondary

MeasureTime frameDescription
Body temperature at 2 hours2 hoursBody temperature at 2 hours refers to a reading taken 100 to 140 minutes after admission
in-hospital mortality30 daysMortality from any cause during hospitalization
3-month mortality rate3 monthsdeath within 3 months after emergency visit
Number of participants with other complications3 monthsincluding heart failure, renal failure, coagulation disorders, respiratory failure, neurological sequelae, etc.

Countries

China

Contacts

CONTACTXiuqin Feng
fengxiuqin@zju.edu.cn13757119151
CONTACTlan chen
jhchenlan2003@hotmail.com13819987120
STUDY_CHAIRlan chen

Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026