跳至主要内容
临床试验/NCT06537557
NCT06537557招募中不适用

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

Second Affiliated Hospital, School of Medicine, Zhejiang University7 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
188
试验地点
7
主要终点
cooling rate at 0.5 hours

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

experimental group

Experimental

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.

干预措施: the early in-hospital temperature management protocol for heat stroke patients (Other)

control group

No Intervention

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.

结局指标

主要结局

cooling rate at 0.5 hours

时间窗: 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

Body temperature at 0.5 hours

时间窗: 0.5 hours

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

次要结局

  • Body temperature at 2 hours(2 hours)
  • in-hospital mortality(30 days)
  • 3-month mortality rate(3 months)
  • Number of participants with other complications(3 months)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (7)

Loading locations...

相似试验