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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05923931

Collaborator

Yiwu Central Hospital (Other), Jinhua People's Hospital (Other), Jinhua Municipal Central Hospital (Other), Dongyang People's Hospital (Other), Lanxi People's Hospital (Other)

196

Enrollment

Locations

Arms

33.1

Anticipated Duration (Months)

32.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

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℃.

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

Outcome Measures

Primary Outcome Measures

the scale of drop in temperature within 2 h [2 hours after admission to emergency department]
The gap between the initial body temperature and the 2-hour body temperature

Secondary Outcome Measures

incidence of organ damage [up to 90 days]
number of participants with organ damage, including but not limited to brain, lung, heart, kidney, liver, and coagulation function
length of ICU stay [up to 90 days]
The length patient stay at ICU
in-hospital mortality [up to 90 days]
number of participants dead in-hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Yiwu Central Hospital	Yiwu	Zhejiang	China
2	Dongyang People's Hospital	Dongyang		China
3	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou		China	310000
4	Jinhua Municipal Central Hospital	Jinhua		China
5	Jinhua People's Hospital	Jinhua		China
6	Lanxi People's Hospital	Lanxi		China

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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05923931

Other Study ID Numbers:

2023-0508

First Posted:

Jun 28, 2023

Last Update Posted:

Jun 28, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University

heat stroke, cooling blanket, cooling rate, outcomes

Additional relevant MeSH terms:

Stroke

Heat Stroke

Sunstroke

Study Results

No Results Posted as of Jun 28, 2023