Heat StrokeNCT06537557
Application of an Early In-Hospital Temperature Management Protocol for Heat Stroke Patients
A study testing the early in-hospital temperature management protocol for heat stroke patients in people with Heat Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 7 sites in China.
Trial summary
Heat stroke is a life-threatening clinical syndrome characterized by an imbalance between heat production and heat dissipation in the body, resulting from exposure to hot and humid environments and/or strenuous exercise. 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?
- the early in-hospital temperature management protocol for heat stroke patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 7 sitesChina
- Study dates
- 1 Jul 2024to 30 Dec 2026
- 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
- Patients admitted to the emergency department and diagnosed with heat stroke according to the China expert consensus on Heat Stroke
Who cannot join
- transferred from another hospital and body temperature < 39.5℃; discharged within 4 hours, and subsequent body temperature or outcomes were unavailable; required immediate cardiopulmonary resuscitation; had other serious diseases, such as massive cerebral haemorrhage or severe trauma.
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
Hanzhou
Xiuqin Feng, PRO, +86 13757119151, fengxiuqin@zju.edu.cn
Lan Chen, M.Med., +86 13819987120
- 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
Zhumei Gong, 179219712@qq.com
About this study
Heat stroke is a life-threatening clinical syndrome characterized by an imbalance between heat production and heat dissipation in the body, resulting from exposure to hot and humid environments and/or strenuous exercise. It is defined by an elevated core temperature exceeding 40°C and central nervous system abnormalities, accompanied by multi-organ dysfunction. The severity of cellular and tissue damage in heat stroke patients depends on the peak temperature reached and the duration of hyperthermia. Rapid reduction of core temperature can halt cellular damage, quickly reverse organ dysfunction, and improve patient outcomes. Therefore, early identification and rapid cooling are crucial to prevent irreversible damage and death in heat stroke patients. However, there is a lack of systematic and specific protocols to guide emergency medical staff in the standardized and effective management of body temperature in heat stroke patients. To address this, our research team previously developed an early in-hospital temperature management protocol for heat stroke patients based on the best available evidence, expert consultations, and expert panel meetings. This study aims to validate the feasibility and effectiveness of the protocol through clinical research, providing a basis for clinical practice.
- Conditions
- Heat Stroke
- Being tested
- the early in-hospital temperature management protocol for heat stroke patients
- Medical subject headings
- Heat Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the early in-hospital temperature management protocol for heat stroke patientsOther
The early in-hospital temperature management protocol for heat stroke includes early identification, selection of cooling methods for rapid cooling, precise target temperature management, and dynamic monitoring. Effective temperature management will be implemented for heat stroke patients to improve their outcomes.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Using the early in-hospital temperature management protocol for heat stroke patients developed in our previous research, we will implement early identification, rapid cooling, and precise target temperature management for this group of patients. Receives: Other: the early in-hospital temperature management protocol for heat stroke patients |
| control group | No intervention | We will retrospectively collect data on heat stroke patients who were visited before the implementation of the early in-hospital temperature management protocol between 2021 and 2022, meaning this group of patients received temperature management according to the original methods used by their respective hospitals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cooling rate at 0.5 hours
The cooling rate at 0.5 hours was calculated in reference to initial body temperature and body temperature at 0.5 hours
Measured: 0.5 hours
Body temperature at 0.5 hours
Body temperature at 0.5 hour refers to a reading obtained 25 to 35 minutes after admission.
Measured: 0.5 hours
Secondary outcomes (4)
Body temperature at 2 hours
Body temperature at 2 hours refers to a reading taken 100 to 140 minutes after admission
Measured: 2 hours
in-hospital mortality
Mortality from any cause during hospitalization
Measured: 30 days
3-month mortality rate
death within 3 months after emergency visit
Measured: 3 months
Number of participants with other complications
including heart failure, renal failure, coagulation disorders, respiratory failure, neurological sequelae, etc.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Jul 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jinhua Municipal Central Hospital, Yiwu Central Hospital, Dongyang People's Hospital, Jinhua People's Hospital, Lanxi People's Hospital, Yongkang No.1 People' s Hospital
- Responsible party
- Sponsor
- Investigators
- lan chen, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537557
- Sponsor's protocol ID
- 2024-0511
- Status last verified
- May 2026
- First submitted
- 28 Jun 2024
- 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
- Application of an Early In-Hospital Temperature Management Protocol for Heat Stroke Patients
- ClinicalTrials.gov ID
- NCT06537557
- Acronym / sponsor ID
- 2024-0511
- Conditions
- Heat Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Jinhua Municipal Central Hospital, Yiwu Central Hospital, Dongyang People's Hospital, Jinhua People's Hospital, Lanxi People's Hospital, Yongkang No.1 People' s Hospital
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Aug 2024 (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.
Heat stroke is a life-threatening clinical syndrome characterized by an imbalance between heat production and heat dissipation in the body, resulting from exposure to hot and humid environments and/or strenuous exercise. It is defined by an elevated core temperature exceeding 40°C and central nervous system abnormalities, accompanied by multi-organ dysfunction. The severity of cellular and tissue damage in heat stroke patients depends on the peak temperature reached and the duration of hyperthermia. Rapid reduction of core temperature can halt cellular damage, quickly reverse organ dysfunction, and improve patient outcomes. Therefore, early identification and rapid cooling are crucial to prevent irreversible damage and death in heat stroke patients. However, there is a lack of systematic and specific protocols to guide emergency medical staff in the standardized and effective management of body temperature in heat stroke patients. To address this, our research team previously developed an early in-hospital temperature management protocol for heat stroke patients based on the best available evidence, expert consultations, and expert panel meetings. This study aims to validate the feasibility and effectiveness of the protocol through clinical research, providing a basis for clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: the early in-hospital temperature management protocol for heat stroke patientsUsing the early in-hospital temperature management protocol for heat stroke patients developed in our previous research, we will implement early identification, rapid cooling, and precise target temperature management for this group of patients. |
| control group | No intervention | –We will retrospectively collect data on heat stroke patients who were visited before the implementation of the early in-hospital temperature management protocol between 2021 and 2022, meaning this group of patients received temperature management according to the original methods used by their respective hospitals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to the emergency department and diagnosed with heat stroke according to the China expert consensus on Heat Stroke
Key exclusion criteria (1 listed)
- transferred from another hospital and body temperature < 39.5℃; discharged within 4 hours, and subsequent body temperature or outcomes were unavailable; required immediate cardiopulmonary resuscitation; had other serious diseases, such as massive cerebral haemorrhage or severe trauma.
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 |
|---|---|---|
| the early in-hospital temperature management protocol for heat stroke patientsThe early in-hospital temperature management protocol for heat stroke includes early identification, selection of cooling methods for rapid cooling, precise target temperature management, and dynamic monitoring. Effective temperature management will be implemented for heat stroke patients to improve their outcomes. | Other | experimental group |
Primary outcome
cooling rate at 0.5 hours
Time frame: 0.5 hours
The cooling rate at 0.5 hours was calculated in reference to initial body temperature and body temperature at 0.5 hours
Body temperature at 0.5 hours
Time frame: 0.5 hours
Body temperature at 0.5 hour refers to a reading obtained 25 to 35 minutes after admission.
4 secondary outcomes
Body temperature at 2 hours
Time frame: 2 hours
in-hospital mortality
Time frame: 30 days
3-month mortality rate
Time frame: 3 months
Number of participants with other complications
Time frame: 3 months
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.
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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 study chair
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 the early in-hospital temperature management protocol for heat stroke patients 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 1 inclusion and 1 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 (13757119151, fengxiuqin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cooling rate at 0.5 hours (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.