Heat StrokeNCT05923931
Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke
A study testing cooling blanket and non-cooling blanket in people with Heat Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 7 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heat Stroke
- What is being tested?
- cooling blanket and non-cooling blanket
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 7 sitesChina
- Study dates
- 28 May 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- diagnosed as heat stroke
- informed consent of patients or family members
Who cannot join
- need immediate cardiopulmonary resuscitation
- body temperature \<39.5℃ on admission
- with the underlying disease of severe organ damage
- pregnant women
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Dongyang People's Hospital
Dongyang
Shuying Xu
- Recruiting
Yongkang No.1 People's Hospital
Guli, Zhejiang, 321300
Huimin Ma, 86-0579-7111834, ykmhm@qq.com
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, 310000
Xiuqin Feng, +8613757119151, fengxiuqin@zju.edu.cn
Lan Chen, +8613819987120, jhchenlan2003@hotmail.com
- Recruiting
Jinhua Municipal Central Hospital
Jinhua
Sunying Wu
- Recruiting
Jinhua People's Hospital
Jinhua
Liyun Lu, 779676709@qq.com
- Recruiting
Lanxi People's Hospital
Lanxi
Xiaoling Yang
- Recruiting
Yiwu Central Hospital
Yiwu, Zhejiang
Zhumei Gong, 179219712@qq.com
About this study
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.
- Conditions
- Heat Stroke
- Being tested
- cooling blanket, non-cooling blanket
- Keywords
- heat stroke, cooling blanket, cooling rate, outcomes
- Medical subject headings
- Heat Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cooling blanketDevice
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 blanketDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| non-cooling blanket group | Experimental | Cooling body temperature by: control the temperature of the emergency room to 20-24℃, 4℃ fluid infusion, ice packs, evaporation, convection, etc. Receives: Device: non-cooling blanket |
| Cooling blanket group | Active comparator | 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℃. Receives: Device: cooling blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
0.5-hour temperature reduction
Calculated as the difference between initial core temperature and core temperature at 0.5 hours after admission.
Measured: 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.
Measured: 0.5 hours after admission to emergency department
Secondary outcomes (4)
Body temperature of 2 hours
Body temperature of 2 hours referred to the temperature value obtained 20 min before and after 2 hours.
Measured: 2 hours
incidence of organ damage
number of participants with organ damage, including but not limited to brain, lung, heart, kidney, liver, and coagulation function
Measured: up to 90 days
length of ICU stay
The length patient stay at ICU
Measured: up to 90 days
in-hospital mortality
number of participants dead in-hospital
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start28 May 2023
- Primary completionOct 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StrokeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Yiwu Central Hospital, Jinhua Municipal Central Hospital, Jinhua People's Hospital, Lanxi People's Hospital, Yongkang No.1 People' s Hospital, Dongyang People's Hospital
- Responsible party
- Sponsor
- Investigators
- Lan Chen, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923931
- Sponsor's protocol ID
- 2023-0508
- Status last verified
- Sep 2025
- First submitted
- 23 May 2023
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke
- ClinicalTrials.gov ID
- NCT05923931
- Acronym / sponsor ID
- 2023-0508
- Conditions
- Heat Stroke
- Keywords
- heat stroke, cooling blanket, cooling rate, outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Yiwu Central Hospital, Jinhua Municipal Central Hospital, Jinhua People's Hospital, Lanxi People's Hospital, Yongkang No.1 People' s Hospital, Dongyang People's Hospital
- Study start
- 28 May 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-cooling blanket group | Experimental | Device: non-cooling blanketCooling 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 comparator | Device: cooling blanketOn 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℃. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years old
- diagnosed as heat stroke
- informed consent of patients or family members
Key exclusion criteria (4 listed)
- need immediate cardiopulmonary resuscitation
- body temperature \<39.5℃ on admission
- with the underlying disease of severe organ damage
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cooling blanketOn 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℃. | Device | Cooling blanket group |
| non-cooling blanketPatients 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. | Device | non-cooling blanket group |
Primary outcome
0.5-hour temperature reduction
Time frame: 0.5 hours
Calculated as the difference between initial core temperature and core temperature at 0.5 hours after admission.
Body temperature of 0.5 hours
Time frame: 0.5 hours after admission to emergency department
Body temperature of 0.5 hours referred to the temperature value obtained 5 min before and after 0.5 hour.
4 secondary outcomes
Body temperature of 2 hours
Time frame: 2 hours
incidence of organ damage
Time frame: up to 90 days
length of ICU stay
Time frame: up to 90 days
in-hospital mortality
Time frame: up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
Related trials for Heat Stroke
Not yet recruiting
Rapid Cool: Heat Stroke Treatment
Hyperthermia
Recruiting
Efficacy of Electric Fans in Children During Heat Waves
Heat Stress, Physiological Stress
Not yet recruiting
Indoor Overheating and Physiological Strain in Older Adults With COPD
Chronic Obstructive Pulmonary Disease (COPD), Heat Stress
Recruiting
Suitability of a 26 °C Indoor Environment for Mitigating Heat Strain in Young Adults
Heat Stress, Physiological Stress
Active, not recruitingObservational study
Mechanism Study of G Protein-coupled Receptor 81 in Multiple Organ Dysfunction of Heat Stroke
Heat Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lan Chen principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cooling blanket and non-cooling blanket in people with Heat Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiuqin Feng (+8613757119151, fengxiuqin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
0.5-hour temperature reduction (time frame: 0.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.