Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Heat Stroke

NCT ID: NCT05155358

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-31

Study Completion Date

2027-12-31

Brief Summary

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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

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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

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Heat Stroke Early Waking MODS Proteinosis Liver Injury Kidney Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

Healthy volunteers

Peripheral blood test

Intervention Type DIAGNOSTIC_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

Patients within the acute phase of disease

Patients within 24 hours after onset

Peripheral blood test

Intervention Type DIAGNOSTIC_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

Recovery stage of disease

Organ dysfunction was corrected, The patient had no obvious discomfort.

Peripheral blood test

Intervention Type DIAGNOSTIC_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

Interventions

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Peripheral blood 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. The patient voluntarily signs an informed consent form;
2. Adult patients who meet the criteria for heat stroke;
3. 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.

Exclusion Criteria

1. Age \<18 years old or \>90 years old;
2. Patients with advanced tumors, Pregnancy or lactation;
3. Patients who missed out during treatment and whose data are incomplete.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yanyan Jia

Role: STUDY_CHAIR

The First Affillated Hospital,the Air Force Medical University

Locations

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The First Affillated Hospital,the Air Force Medical University

Xi'an, Shannxi, China

Site Status

Countries

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China

Central Contacts

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Wen Yin

Role: CONTACT

13809186660 ext. 86

Shanshou Liu

Role: CONTACT

15091332280 ext. 86

Facility Contacts

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Yanyan Jia

Role: primary

84771794 ext. 029

Other Identifiers

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KY20212173

Identifier Type: -

Identifier Source: org_study_id

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