Application of an Early In-Hospital Temperature Management Protocol for Heat Stroke Patients

NCT ID: NCT06537557

Last Updated: 2024-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Heat stroke is a life-threatening clinical syndrome characterized by an imbalance between heat production and heat dissipation in the body, resulting from exposure to hot and humid environments and/or strenuous exercise. It is defined by an elevated core temperature exceeding 40°C and central nervous system abnormalities, accompanied by multi-organ dysfunction. The severity of cellular and tissue damage in heat stroke patients depends on the peak temperature reached and the duration of hyperthermia. Rapid reduction of core temperature can halt cellular damage, quickly reverse organ dysfunction, and improve patient outcomes. Therefore, early identification and rapid cooling are crucial to prevent irreversible damage and death in heat stroke patients. However, there is a lack of systematic and specific protocols to guide emergency medical staff in the standardized and effective management of body temperature in heat stroke patients. To address this, our research team previously developed an early in-hospital temperature management protocol for heat stroke patients based on the best available evidence, expert consultations, and expert panel meetings. This study aims to validate the feasibility and effectiveness of the protocol through clinical research, providing a basis for clinical practice.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heat Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

experimental group

Using the early in-hospital temperature management protocol for heat stroke patients developed in our previous research, we will implement early identification, rapid cooling, and precise target temperature management for this group of patients.

Group Type EXPERIMENTAL

the early in-hospital temperature management protocol for heat stroke patients

Intervention Type OTHER

The early in-hospital temperature management protocol for heat stroke includes early identification, selection of cooling methods for rapid cooling, precise target temperature management, and dynamic monitoring. Effective temperature management will be implemented for heat stroke patients to improve their outcomes.

control group

We will retrospectively collect data on heat stroke patients who were visited before the implementation of the early in-hospital temperature management protocol between 2021 and 2022, meaning this group of patients received temperature management according to the original methods used by their respective hospitals.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

the early in-hospital temperature management protocol for heat stroke patients

The early in-hospital temperature management protocol for heat stroke includes early identification, selection of cooling methods for rapid cooling, precise target temperature management, and dynamic monitoring. Effective temperature management will be implemented for heat stroke patients to improve their outcomes.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients admitted to the emergency department and diagnosed with heat stroke according to the China expert consensus on Heat Stroke

Exclusion Criteria

* transferred from another hospital and body temperature \< 39.5℃; discharged within 4 hours, and subsequent body temperature or outcomes were unavailable; required immediate cardiopulmonary resuscitation; had other serious diseases, such as massive cerebral haemorrhage or severe trauma.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jinhua Municipal Central Hospital

OTHER

Sponsor Role collaborator

Dongyang People's Hospital

OTHER

Sponsor Role collaborator

Lanxi People's Hospital

OTHER

Sponsor Role collaborator

Yiwu Central Hospital

OTHER

Sponsor Role collaborator

Jinhua People&#39;s Hospital

UNKNOWN

Sponsor Role collaborator

Hangzhou Medical College

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

lan chen

Role: STUDY_CHAIR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yongkang First People&#39;s Hospital

Guli, Zhejiang, China

Site Status RECRUITING

Dongyang People's Hospital

Dongyang, , China

Site Status RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hanzhou, , China

Site Status RECRUITING

Jinhua Municipal Central Hospital

Jinhua, , China

Site Status RECRUITING

Jinhua People's Hospital

Jinhua, , China

Site Status RECRUITING

Lanxi People's Hospital

Lanxi, , China

Site Status RECRUITING

Yiwu Central Hospital

Yiwu, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiuqin Feng

Role: CONTACT

13757119151

lan chen

Role: CONTACT

13819987120

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Huimin Ma

Role: primary

86-0579-7111834

Shuying Xu

Role: primary

Xiuqin Feng, PRO

Role: primary

+86 13757119151

Lan Chen, M.Med.

Role: backup

+86 13819987120

Sunying Wu

Role: primary

Liyun Lu

Role: primary

Xiaoling Yang

Role: primary

Zhumei Gong

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-0511

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.