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

Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05155358
• Other study ID #: KY20212173
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: December 2022
• Source: Xijing Hospital
• Contact: Wen Yin
• Phone: 13809186660
• Email: xjyyyw[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Early Waking
• Heat Stroke
• Kidney Injury
• Liver Injury
• MODS
• Proteinosis
• Stroke
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
China	The First Affillated Hospital,the Air Force Medical University	Xi'an	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognosis	Rate of Surviving or Died Participants with Heat Stroke	Day 30 and Day 90
Secondary	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
Secondary	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