- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07346443
Mechanism Study of G Protein-coupled Receptor 81 in Multiple Organ Dysfunction of Heat Stroke
May 26, 2026 updated by: Second Affiliated Hospital of Wenzhou Medical University
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 Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Zhejiang
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Wenzhou, Zhejiang, China, 325000
- Second Affiliated Hospital of Wenzhou Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients who are diagnosed with heatstroke
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 1) Suffering from central nervous system diseases; 2) Long-term use of anticoagulants; 3) Those who refuse to participate or withdraw their informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
heatstroke group
heatstroke patient, no intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Survival status will be assessed over a period of up to 28 days, starting from the date of hospital admission.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Collect the plasma lactic acid level each time when patients with heat stroke are hospitalized
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Plasma lactate levels will be measured at admission and then daily during the hospital stay, for a period of up to 28 days.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
January 31, 2027
Study Registration Dates
First Submitted
January 5, 2026
First Submitted That Met QC Criteria
January 15, 2026
First Posted (Actual)
January 16, 2026
Study Record Updates
Last Update Posted (Actual)
May 29, 2026
Last Update Submitted That Met QC Criteria
May 26, 2026
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAHoWMU-CR2025-03-136
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Study protocol and statistical analysis plan.
IPD Sharing Time Frame
Beginning 6 months after publication with no end date
IPD Sharing Access Criteria
Deidentifed participant data underlying the findings wil be made available upon reasonable request.
proposls fordata acess should be directedto the corresponding author Shengwei Jin
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heat Stroke
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Eagle Pharmaceuticals, Inc.CompletedExertional Heat StrokeSaudi Arabia
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Stanford UniversityCompleted
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-
Second Affiliated Hospital, School of Medicine,...Jinhua People's Hospital; Jinhua Municipal Central Hospital; Yiwu Central Hospital and other collaboratorsRecruiting
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Cairo UniversityRecruitingHeat Stress Disorders | Heat Stroke | Heat Exhaustion | Heat CrampsEgypt
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