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

Sponsor
Xijing Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05155358
Collaborator
(none)
150
1
25
6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Heat Stroke
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Prognosis [Day 30 and Day 90]

    Rate of Surviving or Died Participants with Heat Stroke

Secondary Outcome Measures

  1. Heat Stroke-associated kindey injury [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affillated Hospital,the Air Force Medical University Xi'an Shannxi China 029

Sponsors and Collaborators

  • Xijing Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT05155358
Other Study ID Numbers:
  • KY20212173
First Posted:
Dec 13, 2021
Last Update Posted:
Aug 18, 2022
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022