NCT05923931

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

May 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

2.3 years

First QC Date

May 23, 2023

Last Update Submit

September 18, 2024

Conditions

Heat Stroke

Keywords

heat stroke, cooling blanket, cooling rate, outcomes

Outcome Measures

Primary Outcomes (2)

  • cooling rate at 0.5 hours

    The cooling rate of 0.5h was calculated by the initial temperature and the 0.5 hours temperature.

    0.5 hours

  • Body temperature of 0.5 hours

    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

Secondary Outcomes (4)

  • Body temperature of 2 hours

    2 hours

  • incidence of organ damage

    up to 90 days

  • length of ICU stay

    up to 90 days

  • in-hospital mortality

    up to 90 days

Study Arms (2)

non-cooling blanket group

EXPERIMENTAL

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

Cooling blanket group

ACTIVE COMPARATOR

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

Interventions

cooling blanketDEVICE

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℃.

Cooling blanket group
non-cooling blanketDEVICE

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.

non-cooling blanket group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Yongkang First People's Hospital

Guli, Zhejiang, 321300, China

RECRUITING

Yiwu Central Hospital

Yiwu, Zhejiang, China

RECRUITING

Dongyang People's Hospital

Dongyang, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, 310000, China

RECRUITING

Jinhua Municipal Central Hospital

Jinhua, China

RECRUITING

Jinhua People's Hospital

Jinhua, China

RECRUITING

Lanxi People's Hospital

Lanxi, China

RECRUITING

MeSH Terms

Conditions

Heat Stroke

Condition Hierarchy (Ancestors)

Heat Stress DisordersWounds and Injuries

Study Officials

  • Lan Chen

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuqin Feng

CONTACT

+8613757119151fengxiuqin@zju.edu.cn

Lan Chen

CONTACT

+8613819987120jhchenlan2003@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 28, 2023

Study Start

May 28, 2023

Primary Completion

October 1, 2025

Study Completion

March 1, 2026

Last Updated

September 20, 2024

Record last verified: 2024-09

Locations

CN(7)