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NCT Number: NCT05155358

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.

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Key information

Conditions

Heat Stroke Dyssomnias Early Waking Heat Stress Disorders Kidney Injury Liver Injury MODS Mental Disorders Multiple Organ Failure Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteinosis Shock Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affillated Hospital,the Air Force Medical University

Xi'an, Shannxi, 029, China

Location contact

Yanyan Jia

CONTACT

[email protected]

84771794 ext. 029

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Prognosis

    Time frame: Day 30 and Day 90

    Rate of Surviving or Died Participants with Heat Stroke

Secondary outcomes

  1. Heat Stroke-associated kindey injury

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

    Concentration of Creatinine(Cr)>2 mg/dl or Urine output < 500ml/Day

  2. Heat Stroke-associated liver injury

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

    Concentration of ALT or AST >80 U/L, Concentration of TBIL>2mg/dl（34μmol/l）

Study contacts

Contact information is provided by the study sponsor or research team.

Shanshou Liu

CONTACT

[email protected]

15091332280 ext. 86

Wen Yin

CONTACT

[email protected]

13809186660 ext. 86

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 13, 2021
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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