Early Body Temperature Targets and Relationship With Prognosis in Patients With Heat Stroke

Heat Stroke Clinical Trial

Official title:

Early Body Temperature Targets and Relationship With Prognosis in Patients With Heat Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921682
• Other study ID #: 2023-0517
• Status: Recruiting
• 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: Observational

Clinical Trial Summary

The goal of this observational study is to explore the optimal target body temperature in first 24 hours and the relationship between body temperature and adverse outcomes of heat stroke. The main questions it aims to answer are: - the optimal target body temperature at 0.5 h, 2 h, and the lowest body temperature of heat stroke. - the best body temperature at the cutting point of stop cooling. - The relationship between the volume and speed of ice saline infusion and the cooling effect.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2026
• Est. primary completion date: October 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years; ? diagnosed as heat stroke; ? Informed consent from patients or family members.

Exclusion Criteria:

• need immediate cardiopulmonary resuscitation; ? transferred from another hospital; ? with severe underlying organ insufficiency; ? pregnant women.

Related Conditions & MeSH terms

• Heat Stroke
• Stroke

Intervention

Other:
• observation
This study is an observational study. Patients will receive conventional cooling measures and organ function support.

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	mortality	Number of participants who dead during hospitalization	up to 90 days
Primary	organ damage	Number of participants with organ damage, including but not limited to brain, lung, heart, kidney, liver and coagulation	up to 90 days
Secondary	continuous renal replacement therapy	Number of participants who need CRRT	up to 90 days
Secondary	length of ICU stay	The length patient stay in ICU	up to 90 days
Secondary	length of hospital stay	The length patient stay in hospital	up to 90 days