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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• cooling rate at 0.5 hours [Срок оценки: 0.5 hours]
• Body temperature at 0.5 hours [Срок оценки: 0.5 hours]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• Patients admitted to the emergency department and diagnosed with heat stroke according to the China expert consensus on Heat Stroke

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 7 центров

• 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

Идентификаторы

NCT: NCT06537557 · 2024-0511

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗