Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke

Heat Stroke Clinical Trial

Official title:

Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05923931
• Other study ID #: 2023-0508
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2023
• Est. completion date: March 2026

Study information

• Verified date: May 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xiuqin Feng
• Phone: +8613757119151
• Email: fengxiuqin[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the cooling effect of cooling blanket in patients with heat stroke. The main questions it aims to answer are:

• the cooling rate of cooling blanket in patients with heat stroke

• the relationship between cooling blanket and outcomes in patients with heat stroke

Participants will accept the cooling blanket or non-cooling blanket according to the randomization group.

Researchers will compare cooling rate and outcomes to see if the cooling blanket can accelerate the cooling speed and improve the prognosis of patients in heat stroke.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: March 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years old

• diagnosed as heat stroke

• informed consent of patients or family members

Exclusion Criteria:

• need immediate cardiopulmonary resuscitation

• body temperature <39.5? on admission

• with the underlying disease of severe organ damage

• pregnant women

Related Conditions & MeSH terms

• Heat Stroke
• Stroke

Intervention

Device:
• cooling blanket
On the basis of the cooling methods of non-cooling blanket group, combine the cooling blanket to cool down. The cooling blanket is required to be activated within 30min after admission. The blanket temperature will be set at 4-10?, and the target body temperature is 38?.
• non-cooling blanket
Patients do not receive cooling blanket according to randomization. Cooling body temperature by: control the temperature of the emergency room to 20-24?, 4? fluid infusion, ice packs, evaporation, etc.

Locations

Country	Name	City	State
China	Dongyang People's Hospital	Dongyang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou
China	Jinhua Municipal Central Hospital	Jinhua
China	Jinhua People's Hospital	Jinhua
China	Lanxi People's Hospital	Lanxi
China	Yiwu Central Hospital	Yiwu	Zhejiang

Sponsors (6)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Dongyang People's Hospital, Jinhua Municipal Central Hospital, Jinhua People's Hospital, Lanxi People's Hospital, Yiwu Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the scale of drop in temperature within 2 h	The gap between the initial body temperature and the 2-hour body temperature	2 hours after admission to emergency department
Secondary	incidence of organ damage	number of participants with organ damage, including but not limited to brain, lung, heart, kidney, liver, and coagulation function	up to 90 days
Secondary	length of ICU stay	The length patient stay at ICU	up to 90 days
Secondary	in-hospital mortality	number of participants dead in-hospital	up to 90 days