Early Body Temperature Targets and Relationship With Prognosis in Patients With Heat Stroke

June 18, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

The goal of this observational study is to explore the optimal target body temperature in first 24 hours and the relationship between body temperature and adverse outcomes of heat stroke.

The main questions it aims to answer are:

  • the optimal target body temperature at 0.5 h, 2 h, and the lowest body temperature of heat stroke.
  • the best body temperature at the cutting point of stop cooling.
  • The relationship between the volume and speed of ice saline infusion and the cooling effect.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Dongyang, China
        • Recruiting
        • Dongyang People's Hospital
        • Contact:
          • Shuying Xu
      • Hangzhou, China, 310000
        • Recruiting
        • The second affiliated hospital of zhejiang university school of medicine
        • Contact:
        • Contact:
      • Jinhua, China
        • Recruiting
        • Jinhua municipal central hospital
        • Contact:
          • Sunying Wu
      • Jinhua, China
      • Lanxi, China
        • Recruiting
        • Lanxi People's Hospital
        • Contact:
          • Xiaoling Yang
    • Zhejiang
      • Yiwu, Zhejiang, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Comprehensive tertiary hospital

Description

Inclusion Criteria:

  • ≥ 18 years; ② diagnosed as heat stroke; ③ Informed consent from patients or family members.

Exclusion Criteria:

  • need immediate cardiopulmonary resuscitation; ② transferred from another hospital; ③ with severe underlying organ insufficiency; ④ pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with heat stroke
Patients with heat stroke presenting to the emergency department at the study site
Other: observation
This study is an observational study. Patients will receive conventional cooling measures and organ function support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: up to 90 days
Number of participants who dead during hospitalization
up to 90 days
organ damage
Time Frame: up to 90 days
Number of participants with organ damage, including but not limited to brain, lung, heart, kidney, liver and coagulation
up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of ICU stay
Time Frame: up to 90 days
The length patient stay in ICU
up to 90 days
continuous renal replacement therapy
Time Frame: up to 90 days
Number of participants who need CRRT
up to 90 days
length of hospital stay
Time Frame: up to 90 days
The length patient stay in hospital
up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Jinhua People's Hospital
Jinhua Municipal Central Hospital
Yiwu Central Hospital
Dongyang People's Hospital
Lanxi People's Hospital

Investigators

  • Principal Investigator: Lan Chen, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

June 18, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0517

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heat Stroke

Clinical Trials on observation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe