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

Recruiting

• Conditions: Proteinosis; MODS; Liver Injury; Early Waking; Heat Stroke; Kidney Injury
• Interventions: Diagnostic Test: Peripheral blood test

• Registration Number: NCT05155358
• Lead Sponsor: Xijing Hospital

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.

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 Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-13
• Status Verified: 2022-12
• Last Update Submitted: 2023-01-28
• Last Update Posted: 2023-01-31
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recovery stage of disease	Peripheral blood test	Organ dysfunction was corrected, The patient had no obvious discomfort.
Control group	Peripheral blood test	Healthy volunteers
Patients within the acute phase of disease	Peripheral blood test	Patients within 24 hours after onset

Primary Outcome Measures

Name	Time	Method
Prognosis	Day 30 and Day 90	Rate of Surviving or Died Participants with Heat Stroke

Secondary Outcome Measures

Name	Time	Method
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
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）

Trial Locations

Locations (1)

The First Affillated Hospital,the Air Force Medical University; 🇨🇳 Xi'an, Shannxi, China