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

Overview

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

• 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.

Primary outcome measures

• cooling rate at 0.5 hours [Time frame: 0.5 hours]
• Body temperature at 0.5 hours [Time frame: 0.5 hours]

Secondary outcome measures (4)

• Body temperature at 2 hours [Time frame: 2 hours]
• in-hospital mortality [Time frame: 30 days]
• 3-month mortality rate [Time frame: 3 months]
• Number of participants with other complications [Time frame: 3 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

China · 7 centers

• Yongkang No.1 People's Hospital — Guli
• Dongyang People's Hospital — Dongyang
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hanzhou
• Jinhua Municipal Central Hospital — Jinhua
• Jinhua People's Hospital — Jinhua
• Lanxi People's Hospital — Lanxi
• Yiwu Central Hospital — Yiwu

Identifiers

NCT: NCT06537557 · 2024-0511

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗