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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05923931
Enrollment
126
Registered
2023-06-28
Start date
2023-05-28
Completion date
2027-03-01
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heat Stroke

Keywords

heat stroke, cooling blanket, cooling rate, outcomes

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.

Interventions

DEVICEcooling 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℃.

DEVICEnon-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, convection,etc.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER
Yiwu Central Hospital
CollaboratorOTHER
Jinhua Municipal Central Hospital
CollaboratorOTHER
Jinhua People's Hospital
CollaboratorOTHER
Lanxi People's Hospital
CollaboratorOTHER
Yongkang No.1 People' s Hospital
CollaboratorUNKNOWN
Dongyang People's Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
0.5-hour temperature reduction0.5 hoursCalculated as the difference between initial core temperature and core temperature at 0.5 hours after admission.
Body temperature of 0.5 hours0.5 hours after admission to emergency departmentBody temperature of 0.5 hours referred to the temperature value obtained 5 min before and after 0.5 hour.

Secondary

MeasureTime frameDescription
Body temperature of 2 hours2 hoursBody temperature of 2 hours referred to the temperature value obtained 20 min before and after 2 hours.
incidence of organ damageup to 90 daysnumber of participants with organ damage, including but not limited to brain, lung, heart, kidney, liver, and coagulation function
length of ICU stayup to 90 daysThe length patient stay at ICU
in-hospital mortalityup to 90 daysnumber of participants dead in-hospital

Countries

China

Contacts

CONTACTXiuqin Feng
fengxiuqin@zju.edu.cn+8613757119151
CONTACTLan Chen
jhchenlan2003@hotmail.com+8613819987120
PRINCIPAL_INVESTIGATORLan Chen

Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026