Application of an Early In-Hospital Temperature Management Protocol for Heat Stroke Patients
1 other identifier
interventional
188
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedFirst Posted
Study publicly available on registry
August 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
September 20, 2024
June 1, 2024
2.2 years
June 28, 2024
September 18, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
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.
0.5 hours
Secondary Outcomes (4)
Body temperature at 2 hours
2 hours
in-hospital mortality
30 days
3-month mortality rate
3 months
Number of participants with other complications
3 months
Study Arms (2)
experimental group
EXPERIMENTALUsing 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.
control group
NO INTERVENTIONWe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients admitted to the emergency department and diagnosed with heat stroke according to the China expert consensus on Heat Stroke
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitylead
- Jinhua Municipal Central Hospitalcollaborator
- Dongyang People's Hospitalcollaborator
- Lanxi People's Hospitalcollaborator
- Yiwu Central Hospitalcollaborator
- Jinhua People's Hospitalcollaborator
- Hangzhou Medical Collegecollaborator
Study Sites (7)
Yongkang First People's Hospital
Guli, Zhejiang, 321300, China
Dongyang People's Hospital
Dongyang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou, China
Jinhua Municipal Central Hospital
Jinhua, China
Jinhua People's Hospital
Jinhua, China
Lanxi People's Hospital
Lanxi, China
Yiwu Central Hospital
Yiwu, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
lan chen
Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2024
First Posted
August 5, 2024
Study Start
July 1, 2024
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
September 20, 2024
Record last verified: 2024-06