Heat StrokeNCT05155358
Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Heat Stroke
An observational study of Heat Stroke and Early Waking, run by Xijing Hospital at 1 site in China.
Trial summary
Heat stroke is a clinical syndrome with high incidence and high fatality rate in summer. Patients with liver, kidney, and brain damage are prone to secondary MODS, and the prognosis is poor due to high medical costs. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat Stroke, Early Waking, MODS
- What is being tested?
- Peripheral blood test
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2025to 31 Dec 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Healthy Volunteers with routine physical examination; 2. Heat stroke is defined as heat stroke (Heat Stroke, HS) is a serious fatal disease caused by heat injury factors acting on the body, accompanied by multiple organ(liver,kindey, lung ect) dysfunction.
Who may be able to join
- The patient voluntarily signs an informed consent form;
- Adult patients who meet the criteria for heat stroke;
- Heat stroke is defined as heat stroke (Heat Stroke, HS) is a serious fatal disease caused by heat injury factors acting on the body, accompanied by multiple organ damage.
Who cannot join
- Age <18 years old or >90 years old;
- Patients with advanced tumors, Pregnancy or lactation;
- Patients who missed out during treatment and whose data are incomplete.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affillated Hospital,the Air Force Medical University
Xi'an, Shannxi, 029
Yanyan Jia, 84771794 ext. 029, jiayanyan-2004@hotmail.com
About this study
Heat stroke is a clinical syndrome with high incidence and high fatality rate in summer. Patients with liver, kidney, and brain damage are prone to secondary MODS, and the prognosis is poor due to high medical costs. At present, there is no unified diagnostic criteria for acute liver injury associated with heat stroke, and the commonly used prognosis scores are rarely included in liver injury indicators, which is not good for practicality.
Read the detailed description
The project intends to collect the peripheral blood of the normal population, the 24 hours after the onset of heat stroke and the patients in the recovery period, to separate and extract plasma, PBMC, and plasma exosomal miRNA, and sequence to search for indicators related to disease deterioration and prognosis, construct and verify the early warning and prognosis evaluation system of the disease.
On this basis, the researcher explore cellular and molecular mediated pathological mechanisms of heat stroke, and then clarify the treatment target of heat stroke.
- Conditions
- Heat Stroke, Early Waking, MODS, Proteinosis, Liver Injury, Kidney Injury
- Being tested
- Peripheral blood test
- Medical subject headings
- Heat Stroke, Sleep Initiation and Maintenance Disorders, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood testDiagnostic test
Collect peripheral blood to separate and extract plasma, PBMC, and plasma exosomal miRNA, and sequence to find indicators related to disease deterioration and prognosis
| Study group | Role | What they receive |
|---|---|---|
| Control group | Healthy volunteers Receives: Diagnostic Test: Peripheral blood test | |
| Patients within the acute phase of disease | Patients within 24 hours after onset Receives: Diagnostic Test: Peripheral blood test | |
| Recovery stage of disease | Organ dysfunction was corrected, The patient had no obvious discomfort. Receives: Diagnostic Test: Peripheral blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognosis
Rate of Surviving or Died Participants with Heat Stroke
Measured: Day 30 and Day 90
Secondary outcomes (2)
Heat Stroke-associated kindey injury
Concentration of Creatinine(Cr)>2 mg/dl or Urine output < 500ml/Day
Measured: Day 0, Day 7 and On the day of discharge after improvement
Heat Stroke-associated liver injury
Concentration of ALT or AST >80 U/L, Concentration of TBIL>2mg/dl（34μmol/l）
Measured: Day 0, Day 7 and On the day of discharge after improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start31 Aug 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanyan Jia, Study chair, The First Affillated Hospital,the Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155358
- Sponsor's protocol ID
- KY20212173
- Status last verified
- Aug 2025
- First submitted
- 8 Dec 2021
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Heat Stroke
- ClinicalTrials.gov ID
- NCT05155358
- Acronym / sponsor ID
- KY20212173
- Conditions
- Heat Stroke, Early Waking, MODS, Proteinosis, Liver Injury, Kidney Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Dec 2021 (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 clinical syndrome with high incidence and high fatality rate in summer. Patients with liver, kidney, and brain damage are prone to secondary MODS, and the prognosis is poor due to high medical costs. At present, there is no unified diagnostic criteria for acute liver injury associated with heat stroke, and the commonly used prognosis scores are rarely included in liver injury indicators, which is not good for practicality.
Detailed description
The project intends to collect the peripheral blood of the normal population, the 24 hours after the onset of heat stroke and the patients in the recovery period, to separate and extract plasma, PBMC, and plasma exosomal miRNA, and sequence to search for indicators related to disease deterioration and prognosis, construct and verify the early warning and prognosis evaluation system of the disease.
On this basis, the researcher explore cellular and molecular mediated pathological mechanisms of heat stroke, and then clarify the treatment target of heat stroke.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: Peripheral blood testHealthy volunteers |
| Patients within the acute phase of disease | – | Diagnostic Test: Peripheral blood testPatients within 24 hours after onset |
| Recovery stage of disease | – | Diagnostic Test: Peripheral blood testOrgan dysfunction was corrected, The patient had no obvious discomfort. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Healthy Volunteers with routine physical examination; 2. Heat stroke is defined as heat stroke (Heat Stroke, HS) is a serious fatal disease caused by heat injury factors acting on the body, accompanied by multiple organ(liver,kindey, lung ect) dysfunction.
Key inclusion criteria (3 listed)
- The patient voluntarily signs an informed consent form;
- Adult patients who meet the criteria for heat stroke;
- Heat stroke is defined as heat stroke (Heat Stroke, HS) is a serious fatal disease caused by heat injury factors acting on the body, accompanied by multiple organ damage.
Key exclusion criteria (3 listed)
- Age <18 years old or >90 years old;
- Patients with advanced tumors, Pregnancy or lactation;
- Patients who missed out during treatment and whose data are incomplete.
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 |
|---|---|---|
| Peripheral blood testCollect peripheral blood to separate and extract plasma, PBMC, and plasma exosomal miRNA, and sequence to find indicators related to disease deterioration and prognosis | Diagnostic test | Control group, Patients within the acute phase of disease, Recovery stage of disease |
Primary outcome
Prognosis
Time frame: Day 30 and Day 90
Rate of Surviving or Died Participants with Heat Stroke
2 secondary outcomes
Heat Stroke-associated kindey injury
Time frame: Day 0, Day 7 and On the day of discharge after improvement
Heat Stroke-associated liver injury
Time frame: Day 0, Day 7 and On the day of discharge after improvement
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 14 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Heat Stroke
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Indoor Overheating and Physiological Strain in Older Adults With COPD
Chronic Obstructive Pulmonary Disease (COPD), Heat Stress
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Rapid Cool: Heat Stroke Treatment
Hyperthermia
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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.
Yanyan Jia study chair
The First Affillated Hospital,the Air Force Medical University
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 and Early Waking, run by Xijing Hospital 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 Aug 2025. 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?
Contact Wen Yin (13809186660 ext. 86, xjyyyw@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognosis (time frame: Day 30 and Day 90). 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 14 Aug 2025.