Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05923931

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yongkang No.1 People's Hospital, Guli, Zhejiang, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cooling blanket

Device

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℃.

non-cooling blanket

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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. 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

  3. length of ICU stay

    Time frame: up to 90 days

    The length patient stay at ICU

  4. in-hospital mortality

    Time frame: up to 90 days

    number of participants dead in-hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Dongyang People's Hospital
  • Jinhua Municipal Central Hospital
  • Jinhua People's Hospital
  • Lanxi People's Hospital
  • Yiwu Central Hospital
  • Yongkang No.1 People' s Hospital

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 28, 2023
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.