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

NCT05155358 | Not Yet Recruiting

• 1 other identifier: KY20212173
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heat Stroke; Early Waking; MODS; Proteinosis; Liver Injury; Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Prognosis

  Rate of Surviving or Died Participants with Heat Stroke

  Day 30 and Day 90

Secondary Outcomes (2)

• Heat Stroke-associated kindey injury

  Day 0, Day 7 and On the day of discharge after improvement

• Heat Stroke-associated liver injury

  Day 0, Day 7 and On the day of discharge after improvement

Study Arms (3)

Control group

Healthy volunteers

Diagnostic Test: Peripheral blood test

Patients within the acute phase of disease

Patients within 24 hours after onset

Diagnostic Test: Peripheral blood test

Recovery stage of disease

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

Diagnostic Test: Peripheral blood test

Interventions

Peripheral blood test 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

Control group; Patients within the acute phase of disease; Recovery stage of disease

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

The First Affillated Hospital,the Air Force Medical University

Xi'an, Shannxi, 029, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, PBMC, plasma exosome miRNA

MeSH Terms

Conditions

Heat Stroke; Sleep Initiation and Maintenance Disorders; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Heat Stress Disorders; Wounds and Injuries; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yanyan Jia

  The First Affillated Hospital,the Air Force Medical University

  STUDY CHAIR

Central Study Contacts

Wen Yin

CONTACT

13809186660; xjyyyw@126.com

Shanshou Liu

CONTACT

15091332280; shanshouliu@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 13, 2021
• Study Start: August 31, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)