Clinical trial NCT06537557: Application of an Early In-Hospital Temperature Management Protocol for Heat Stroke Patients
Official title: Application of an Early In-Hospital Temperature Management Protocol for Heat Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heat Stroke
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Jinhua Municipal Central Hospital
name: Dongyang People's Hospital
name: Lanxi People's Hospital
name: Yiwu Central Hospital
name: Jinhua People&#39;s Hospital
name: Hangzhou Medical College
First posted: 2024-08-05
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: cooling rate at 0.5 hours
timeFrame: 0.5 hours
measure: Body temperature at 0.5 hours
timeFrame: 0.5 hours
Secondary outcomes:
measure: Body temperature at 2 hours
timeFrame: 2 hours
measure: in-hospital mortality
timeFrame: 30 days
measure: 3-month mortality rate
timeFrame: 3 months
measure: Number of participants with other complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Yongkang
country: China
facility: Yongkang First People&#39;s Hospital
state: Zhejiang
city: Dongyang
country: China
facility: Dongyang People's Hospital
city: Hanzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
city: Jinhua
country: China
facility: Jinhua People's Hospital
city: Lanxi
country: China
facility: Lanxi People's Hospital
city: Yiwu
country: China
facility: Yiwu Central Hospital
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: lan chen
role: STUDY_CHAIR
References: