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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Injury; Liver Injury; Heat Stroke; Early Waking; Proteinosis; MODS
• Intervention / Treatment: Diagnostic test: Peripheral blood test

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Wen Yin; Phone Number: 86 13809186660; Email: xjyyyw@126.com
• Study Contact Backup: Name: Shanshou Liu; Phone Number: 86 15091332280; Email: shanshouliu@126.com

Study Locations

• China
  • Shannxi
    • Xi'an, Shannxi, China, 029
      • The First Affillated Hospital,the Air Force Medical University
      • Contact: Yanyan Jia; Phone Number: 029 84771794; Email: jiayanyan-2004@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Healthy volunteers	Diagnostic test: 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
Patients within the acute phase of disease; Patients within 24 hours after onset	Diagnostic test: 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
Recovery stage of disease; Organ dysfunction was corrected, The patient had no obvious discomfort.	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognosis	Rate of Surviving or Died Participants with Heat Stroke	Day 30 and Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heat Stroke-associated kindey injury	Concentration of Creatinine(Cr)>2 mg/dl or Urine output < 500ml/Day	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）	Day 0, Day 7 and On the day of discharge after improvement

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Yanyan Jia, The First Affillated Hospital,the Air Force Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 10, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heat Stress Disorders; Stroke; Wounds and Injuries; Heat Stroke; Sunstroke
• Other Study ID Numbers: KY20212173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No