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NCT Number: NCT06537557

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yongkang No.1 People's Hospital, Guli, Zhejiang, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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.

Primary outcomes

  1. cooling rate at 0.5 hours

    Time frame: 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

  2. Body temperature at 0.5 hours

    Time frame: 0.5 hours

    Body temperature at 0.5 hour refers to a reading obtained 25 to 35 minutes after admission.

Secondary outcomes

  1. Body temperature at 2 hours

    Time frame: 2 hours

    Body temperature at 2 hours refers to a reading taken 100 to 140 minutes after admission

  2. in-hospital mortality

    Time frame: 30 days

    Mortality from any cause during hospitalization

  3. 3-month mortality rate

    Time frame: 3 months

    death within 3 months after emergency visit

  4. Number of participants with other complications

    Time frame: 3 months

    including heart failure, renal failure, coagulation disorders, respiratory failure, neurological sequelae, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiuqin Feng

CONTACT

[email protected]

13757119151

lan chen

CONTACT

[email protected]

13819987120

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Dongyang People's Hospital
  • Jinhua Municipal Central Hospital
  • Jinhua People's Hospital
  • Lanxi People's Hospital
  • Yiwu Central Hospital
  • Yongkang No.1 People' s Hospital

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2024
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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