NCT07346443

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Mar 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Mar 2026Jan 2027

First Submitted

Initial submission to the registry

January 5, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 5, 2026

Last Update Submit

January 15, 2026

Conditions

Keywords

G protein-coupled receptor 81Lactic Acidheat stroke

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    Plasma lactate levels will be measured at admission and then daily during the hospital stay, for a period of up to 28 days.

Study Arms (1)

heatstroke group

heatstroke patient, no intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who are diagnosed with heatstroke

You may qualify if:

  • \) 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.

You may not qualify if:

  • \) Suffering from central nervous system diseases; 2) Long-term use of anticoagulants; 3) Those who refuse to participate or withdraw their informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heat Stroke

Condition Hierarchy (Ancestors)

Heat Stress DisordersWounds and Injuries

Central Study Contacts

Jin Shengwei, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 16, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Study protocol and statistical analysis plan.

Shared Documents
SAP
Time Frame
Beginning 6 months after publication with no end date
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
More information