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Not yet recruitingNCT05155358Updated Aug 14, 2025

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

An observational study in Heat Stroke, Early Waking and MODS, sponsored by Xijing Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by Xijing Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Heat Stroke
  • Early Waking
  • MODS
  • Proteinosis
  • Liver Injury
  • Kidney Injury
03

In context

Heat Stroke

21 studies on the registry are indexed under Heat Stroke; 10 are open to participants now.

Browse Heat Stroke studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The patient voluntarily signs an 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Diagnostic testPeripheral 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

06

What researchers measure

Primary outcomes

  1. Prognosis

    Rate of Surviving or Died Participants with Heat Stroke

    Time frame: Day 30 and Day 90

Secondary outcomes

  1. Heat Stroke-associated kindey injury

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

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

  2. Heat Stroke-associated liver injury

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

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2025; primary completion for Jun 2027, 21 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2021
First posted
Dec 13, 2021
StartEst.
Aug 31, 2025
Primary completionEst.
Jun 30, 2027
CompletionEst.
Dec 31, 2027
Last update
Aug 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05155358
Lead sponsor
Xijing Hospital
Responsible party
Sponsor
First posted
Dec 13, 2021
Start date
Aug 31, 2025 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 14, 2025

Study contacts

Wen Yin
Contact
xjyyyw@126.com
13809186660 ext. 86
Shanshou Liu
Contact
shanshouliu@126.com
15091332280 ext. 86
Yanyan Jia
study chair · The First Affillated Hospital,the Air Force Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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