The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05923931
Recruitment Status : Recruiting
First Posted : June 28, 2023
Last Update Posted : June 28, 2023
Sponsor:
Collaborators:
Yiwu Central Hospital
Jinhua People's Hospital
Jinhua Municipal Central Hospital
Dongyang People's Hospital
Lanxi People's Hospital
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Heat Stroke Device: cooling blanket Device: non-cooling blanket Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke
Actual Study Start Date : May 28, 2023
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : March 2026
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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, 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, etc.
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℃.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. the scale of drop in temperature within 2 h [ Time Frame: 2 hours after admission to emergency department ]
    The gap between the initial body temperature and the 2-hour body temperature


Secondary Outcome Measures :
  1. 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

  2. length of ICU stay [ Time Frame: up to 90 days ]
    The length patient stay at ICU

  3. in-hospital mortality [ Time Frame: up to 90 days ]
    number of participants dead in-hospital


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05923931


Contacts
Layout table for location contacts
Contact: Xiuqin Feng +8613757119151 fengxiuqin@zju.edu.cn
Contact: Lan Chen +8613819987120 jhchenlan2003@hotmail.com

Locations
Layout table for location information
China, Zhejiang
Yiwu Central Hospital Recruiting
Yiwu, Zhejiang, China
Contact: Zhumei Gong       179219712@qq.com   
China
Dongyang People's Hospital Recruiting
Dongyang, China
Contact: Shuying Xu         
The Second Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, China, 310000
Contact: Xiuqin Feng    +8613757119151    fengxiuqin@zju.edu.cn   
Contact: Lan Chen    +8613819987120    jhchenlan2003@hotmail.com   
Jinhua Municipal Central Hospital Recruiting
Jinhua, China
Contact: Sunying Wu         
Jinhua People's Hospital Recruiting
Jinhua, China
Contact: Liyun Lu       779676709@qq.com   
Lanxi People's Hospital Recruiting
Lanxi, China
Contact: Xiaoling Yang         
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Yiwu Central Hospital
Jinhua People's Hospital
Jinhua Municipal Central Hospital
Dongyang People's Hospital
Lanxi People's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Lan Chen Second Affiliated Hospital, School of Medicine, Zhejiang University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT05923931    
Other Study ID Numbers: 2023-0508
First Posted: June 28, 2023    Key Record Dates
Last Update Posted: June 28, 2023
Last Verified: May 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
heat stroke, cooling blanket, cooling rate, outcomes
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Heat Stroke
Sunstroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Heat Stress Disorders
Wounds and Injuries