Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke
1 other identifier
interventional
126
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2023
CompletedStudy Start
First participant enrolled
May 28, 2023
CompletedFirst Posted
Study publicly available on registry
June 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
May 27, 2026
September 1, 2025
3.3 years
May 23, 2023
May 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
0.5-hour temperature reduction
Calculated as the difference between initial core temperature and core temperature at 0.5 hours after admission.
0.5 hours
Body temperature of 0.5 hours
Body temperature of 0.5 hours referred to the temperature value obtained 5 min before and after 0.5 hour.
0.5 hours after admission to emergency department
Secondary Outcomes (4)
Body temperature of 2 hours
2 hours
incidence of organ damage
up to 90 days
length of ICU stay
up to 90 days
in-hospital mortality
up to 90 days
Study Arms (2)
non-cooling blanket group
EXPERIMENTALCooling body temperature by: control the temperature of the emergency room to 20-24℃, 4℃ fluid infusion, ice packs, evaporation, convection, etc.
Cooling blanket group
ACTIVE COMPARATOROn 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℃.
Interventions
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℃.
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, convection,etc.
Eligibility Criteria
You may qualify if:
- ≥ 18 years old
- diagnosed as heat stroke
- informed consent of patients or family members
You may not qualify if:
- need immediate cardiopulmonary resuscitation
- body temperature \<39.5℃ on admission
- with the underlying disease of severe organ damage
- pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yiwu Central Hospitalcollaborator
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitylead
- Jinhua Municipal Central Hospitalcollaborator
- Jinhua People's Hospitalcollaborator
- Lanxi People's Hospitalcollaborator
- Yongkang No.1 People' s Hospitalcollaborator
- Dongyang People's Hospitalcollaborator
Study Sites (7)
Yongkang No.1 People's Hospital
Guli, Zhejiang, 321300, China
Yiwu Central Hospital
Yiwu, Zhejiang, China
Dongyang People's Hospital
Dongyang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, 310000, China
Jinhua Municipal Central Hospital
Jinhua, China
Jinhua People's Hospital
Jinhua, China
Lanxi People's Hospital
Lanxi, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lan Chen
Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2023
First Posted
June 28, 2023
Study Start
May 28, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
May 27, 2026
Record last verified: 2025-09