Heat StrokeNCT07346443
Mechanism Study of G Protein-coupled Receptor 81 in Multiple Organ Dysfunction of Heat Stroke
An observational study of Heat Stroke, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Heat stroke is one of the common acute and critical conditions in the ICU, characterized by a high incidence and mortality rate, and there is still a lack of effective and precise treatment methods. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heat Stroke
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 31 Jan 2027
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who are diagnosed with heatstroke
Who may be able to join
- 1) There was a clear history of high-temperature exposure before the onset of the disease; 2) Core body temperature ≥40℃ upon admission or within 2 hours of onset; 3) At least one abnormal symptom of the central nervous system occurs 4) Sign an informed consent form or have their legal representative agree to participate in the research.
Who cannot join
- 1) Suffering from central nervous system diseases; 2) Long-term use of anticoagulants; 3) Those who refuse to participate or withdraw their informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
Heat stroke is one of the common acute and critical conditions in the ICU, characterized by a high incidence and mortality rate, and there is still a lack of effective and precise treatment methods. The latest research indicates that G protein-coupled receptor 81 (GPR81), as an endogenous receptor of lactic acid, can regulate immune responses by up-regulating the expression of inflammatory factors and the chemotaxis of neutrophils, suggesting that the GPR81 receptor may play a potential key role in heat stroke. The investigators aim to reveal the position and key role of GPR81 in improving multiple organ dysfunction caused by heat stroke, and to clarify its specific molecular mechanism, with the goal of providing new ideas for the prevention and treatment of heat stroke based on lactate levels, a commonly used clinical indicator.
- Conditions
- Heat Stroke
- Keywords
- G protein-coupled receptor 81, Lactic Acid, heat stroke
- Medical subject headings
- Heat Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| heatstroke group | heatstroke patient, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 28-day survival rate of patients with heat stroke
For patients with heat stroke, if they die within 28 days, it indicates they are non-survivors; if they do not die within 28 days, it indicates they are survivors
Measured: Survival status will be assessed over a period of up to 28 days, starting from the date of hospital admission.
Secondary outcomes (1)
Plasma lactate levels in patients with heat stroke
Collect the plasma lactic acid level each time when patients with heat stroke are hospitalized
Measured: Plasma lactate levels will be measured at admission and then daily during the hospital stay, for a period of up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 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 of Wenzhou Medical UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346443
- Sponsor's protocol ID
- SAHoWMU-CR2025-03-136
- Status last verified
- Nov 2025
- First submitted
- 5 Jan 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and statistical analysis plan.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism Study of G Protein-coupled Receptor 81 in Multiple Organ Dysfunction of Heat Stroke
- ClinicalTrials.gov ID
- NCT07346443
- Acronym / sponsor ID
- SAHoWMU-CR2025-03-136
- Conditions
- Heat Stroke
- Keywords
- G protein-coupled receptor 81, Lactic Acid, heat stroke
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 16 Jan 2026 (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 one of the common acute and critical conditions in the ICU, characterized by a high incidence and mortality rate, and there is still a lack of effective and precise treatment methods. The latest research indicates that G protein-coupled receptor 81 (GPR81), as an endogenous receptor of lactic acid, can regulate immune responses by up-regulating the expression of inflammatory factors and the chemotaxis of neutrophils, suggesting that the GPR81 receptor may play a potential key role in heat stroke. The investigators aim to reveal the position and key role of GPR81 in improving multiple organ dysfunction caused by heat stroke, and to clarify its specific molecular mechanism, with the goal of providing new ideas for the prevention and treatment of heat stroke based on lactate levels, a commonly used clinical indicator.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| heatstroke group | – | –heatstroke patient, no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who are diagnosed with heatstroke
Key inclusion criteria (1 listed)
- 1) There was a clear history of high-temperature exposure before the onset of the disease; 2) Core body temperature ≥40℃ upon admission or within 2 hours of onset; 3) At least one abnormal symptom of the central nervous system occurs 4) Sign an informed consent form or have their legal representative agree to participate in the research.
Key exclusion criteria (1 listed)
- 1) Suffering from central nervous system diseases; 2) Long-term use of anticoagulants; 3) Those who refuse to participate or withdraw their informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The 28-day survival rate of patients with heat stroke
Time frame: Survival status will be assessed over a period of up to 28 days, starting from the date of hospital admission.
For patients with heat stroke, if they die within 28 days, it indicates they are non-survivors; if they do not die within 28 days, it indicates they are survivors
1 secondary outcome
Plasma lactate levels in patients with heat stroke
Time frame: Plasma lactate levels will be measured at admission and then daily during the hospital stay, for a period of up to 28 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 29 May 2026.
- Individual participant dataSharing planned: Yes. Study protocol and statistical analysis plan.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heat Stroke, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site 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: under way, not looking for participants, as of the sponsor's last update on 29 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 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 28-day survival rate of patients with heat stroke (time frame: Survival status will be assessed over a period of up to 28 days, starting from the date of hospital admission.). 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 29 May 2026.