Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke

May 24, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

The goal of this clinical trial is to test the cooling effect of cooling blanket in patients with heat stroke. The main questions it aims to answer are:

  • the cooling rate of cooling blanket in patients with heat stroke
  • the relationship between cooling blanket and outcomes in patients with heat stroke

Participants will accept the cooling blanket or non-cooling blanket according to the randomization group.

Researchers will compare cooling rate and outcomes to see if the cooling blanket can accelerate the cooling speed and improve the prognosis of patients in heat stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

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
      • Guli, Zhejiang, China, 321300
        • Recruiting
        • Yongkang No.1 People's Hospital
        • Contact:
          • Huimin Ma
          • Phone Number: 86-0579-7111834
          • Email: ykmhm@qq.com
      • 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

No

Description

Inclusion Criteria:

  • ≥ 18 years old
  • diagnosed as heat stroke
  • informed consent of patients or family members

Exclusion Criteria:

  • need immediate cardiopulmonary resuscitation
  • body temperature <39.5℃ on admission
  • with the underlying disease of severe organ damage
  • 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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cooling blanket group
On the basis of the cooling methods of non-cooling blanket group, combine the cooling blanket to cool down. The cooling blanket is required to be activated within 30min after admission. The blanket temperature will be set at 4-10℃, and the target body temperature is 38℃.
Device: cooling blanket
On the basis of the cooling methods of non-cooling blanket group, combine the cooling blanket to cool down. The cooling blanket is required to be activated within 30min after admission. The blanket temperature will be set at 4-10℃, and the target body temperature is 38℃.
Experimental: non-cooling blanket group
Cooling body temperature by: control the temperature of the emergency room to 20-24℃, 4℃ fluid infusion, ice packs, evaporation, convection, etc.
Device: non-cooling blanket
Patients do not receive cooling blanket according to randomization. Cooling body temperature by: control the temperature of the emergency room to 20-24℃, 4℃ fluid infusion, ice packs, evaporation, convection,etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body temperature of 0.5 hours
Time Frame: 0.5 hours after admission to emergency department
Body temperature of 0.5 hours referred to the temperature value obtained 5 min before and after 0.5 hour.
0.5 hours after admission to emergency department
0.5-hour temperature reduction
Time Frame: 0.5 hours
Calculated as the difference between initial core temperature and core temperature at 0.5 hours after admission.
0.5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of 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 function
up to 90 days
length of ICU stay
Time Frame: up to 90 days
The length patient stay at ICU
up to 90 days
in-hospital mortality
Time Frame: up to 90 days
number of participants dead in-hospital
up to 90 days
Body temperature of 2 hours
Time Frame: 2 hours
Body temperature of 2 hours referred to the temperature value obtained 20 min before and after 2 hours.
2 hours

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
Yongkang No.1 People' s 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, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

June 20, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 24, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0508

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.

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