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

Primary Purpose

Heat Stroke

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cooling blanket
non-cooling blanket
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heat Stroke focused on measuring heat stroke, cooling blanket, cooling rate, outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yiwu Central HospitalRecruiting
  • Dongyang People's HospitalRecruiting
  • The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
  • Jinhua Municipal Central HospitalRecruiting
  • Jinhua People's HospitalRecruiting
  • Lanxi People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

non-cooling blanket group

Cooling blanket group

Arm Description

Cooling body temperature by: control the temperature of the emergency room to 20-24℃, 4℃ fluid infusion, ice packs, evaporation, etc.

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℃.

Outcomes

Primary Outcome Measures

the scale of drop in temperature within 2 h
The gap between the initial body temperature and the 2-hour body temperature

Secondary Outcome Measures

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

Full Information

First Posted
May 23, 2023
Last Updated
June 20, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Yiwu Central Hospital, Jinhua People's Hospital, Jinhua Municipal Central Hospital, Dongyang People's Hospital, Lanxi People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05923931
Brief Title
Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke
Official Title
Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2023 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Yiwu Central Hospital, Jinhua People's Hospital, Jinhua Municipal Central Hospital, Dongyang People's Hospital, Lanxi People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heat Stroke
Keywords
heat stroke, cooling blanket, cooling rate, outcomes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
non-cooling blanket group
Arm Type
Experimental
Arm Description
Cooling body temperature by: control the temperature of the emergency room to 20-24℃, 4℃ fluid infusion, ice packs, evaporation, etc.
Arm Title
Cooling blanket group
Arm Type
Active Comparator
Arm Description
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℃.
Intervention Type
Device
Intervention Name(s)
cooling blanket
Intervention Description
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℃.
Intervention Type
Device
Intervention Name(s)
non-cooling blanket
Intervention Description
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.
Primary Outcome Measure Information:
Title
the scale of drop in temperature within 2 h
Description
The gap between the initial body temperature and the 2-hour body temperature
Time Frame
2 hours after admission to emergency department
Secondary Outcome Measure Information:
Title
incidence of organ damage
Description
number of participants with organ damage, including but not limited to brain, lung, heart, kidney, liver, and coagulation function
Time Frame
up to 90 days
Title
length of ICU stay
Description
The length patient stay at ICU
Time Frame
up to 90 days
Title
in-hospital mortality
Description
number of participants dead in-hospital
Time Frame
up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuqin Feng
Phone
+8613757119151
Email
fengxiuqin@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lan Chen
Phone
+8613819987120
Email
jhchenlan2003@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lan Chen
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yiwu Central Hospital
City
Yiwu
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhumei Gong
Email
179219712@qq.com
Facility Name
Dongyang People's Hospital
City
Dongyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuying Xu
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuqin Feng
Phone
+8613757119151
Email
fengxiuqin@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Lan Chen
Phone
+8613819987120
Email
jhchenlan2003@hotmail.com
Facility Name
Jinhua Municipal Central Hospital
City
Jinhua
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunying Wu
Facility Name
Jinhua People's Hospital
City
Jinhua
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liyun Lu
Email
779676709@qq.com
Facility Name
Lanxi People's Hospital
City
Lanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoling Yang

12. IPD Sharing Statement

Learn more about this trial

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

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