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

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.

Study Overview

• Status: Recruiting
• Conditions: Heat Stroke
• Intervention / Treatment: Other: the early in-hospital temperature management protocol for heat stroke patients

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiuqin Feng; Phone Number: 13757119151; Email: fengxiuqin@zju.edu.cn
• Study Contact Backup: Name: lan chen; Phone Number: 13819987120; Email: jhchenlan2003@hotmail.com

Study Locations

• China
  • Dongyang, China
    • Recruiting
    • Dongyang People's Hospital
    • Contact: Shuying Xu
  • Hanzhou, China
    • Recruiting
    • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Contact: Xiuqin Feng, PRO; Phone Number: +86 13757119151; Email: fengxiuqin@zju.edu.cn
    • Contact: Lan Chen, M.Med.; Phone Number: +86 13819987120
  • Jinhua, China
    • Recruiting
    • Jinhua municipal central hospital
    • Contact: Sunying Wu
  • Jinhua, China
    • Recruiting
    • Jinhua People's Hospital
    • Contact: Liyun Lu; Email: 779676709@qq.com
  • Lanxi, China
    • Recruiting
    • Lanxi People's Hospital
    • Contact: Xiaoling Yang
  • Yiwu, China
    • Recruiting
    • Yiwu Central Hospital
    • Contact: Zhumei Gong; Email: 179219712@qq.com
  • Zhejiang
    • Guli, Zhejiang, China, 321300
      • Recruiting
      • Yongkang No.1 People's Hospital
      • Contact: Huimin Ma; Phone Number: 86-0579-7111834; Email: ykmhm@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; 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; 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.
No Intervention: control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body temperature at 2 hours	Body temperature at 2 hours refers to a reading taken 100 to 140 minutes after admission	2 hours
in-hospital mortality	Mortality from any cause during hospitalization	30 days
3-month mortality rate	death within 3 months after emergency visit	3 months
Number of participants with other complications	including heart failure, renal failure, coagulation disorders, respiratory failure, neurological sequelae, etc.	3 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Jinhua People's Hospital; Jinhua Municipal Central Hospital; Yiwu Central Hospital; Yongkang No.1 People' s Hospital; Dongyang People's Hospital; Lanxi People's Hospital
• Investigators: Study Chair: lan chen, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Heat Stress Disorders; Heat Stroke
• Other Study ID Numbers: 2024-0511

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No