ClinicalTrials.gg
RecruitingNCT05923931Updated May 27, 2026

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

An interventional study of cooling blanket and non-cooling blanket in Heat Stroke, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 7 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heat Stroke

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Keywords

  • heat stroke, cooling blanket, cooling rate, outcomes
03

In context

Heat Stroke

21 studies on the registry are indexed under Heat Stroke; 10 are open to participants now.

This study's planned enrollment of 126 is above the median of 34 across 13 interventional studies indexed under Heat Stroke.

Browse Heat Stroke studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • need immediate cardiopulmonary resuscitation
  • body temperature \<39.5℃ on admission
  • with the underlying disease of severe organ damage
  • pregnant women
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
126 participants (estimated)

Study arms

  • 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, convection, etc.

    Device: non-cooling blanket

  • 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

Interventions

  • Devicecooling 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℃.

  • Devicenon-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, convection,etc.

06

What researchers measure

Primary outcomes

  1. 0.5-hour temperature reduction

    Calculated as the difference between initial core temperature and core temperature at 0.5 hours after admission.

    Time frame: 0.5 hours

  2. 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.

    Time frame: 0.5 hours after admission to emergency department

Secondary outcomes

  1. Body temperature of 2 hours

    Body temperature of 2 hours referred to the temperature value obtained 20 min before and after 2 hours.

    Time frame: 2 hours

  2. incidence of organ damage

    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

  3. length of ICU stay

    The length patient stay at ICU

    Time frame: up to 90 days

  4. in-hospital mortality

    number of participants dead in-hospital

    Time frame: up to 90 days

07

Study locations

7 of 7 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2023 (actual). Primary completion is estimated for Oct 2026, 41 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2023
First posted
Jun 28, 2023
StartActual
May 28, 2023
Primary completionEst.
Oct 2026
CompletionEst.
Mar 2027
Last update
May 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05923931
Collaborators
Yiwu Central Hospital, Jinhua Municipal Central Hospital, Jinhua People's Hospital, Lanxi People's Hospital, Yongkang No.1 People' s Hospital, Dongyang People's Hospital
Responsible party
Sponsor
First posted
Jun 28, 2023
Start date
May 28, 2023
Primary completion
Oct 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
May 27, 2026

Study contacts

Xiuqin Feng
Contact
fengxiuqin@zju.edu.cn
+8613757119151
Lan Chen
Contact
jhchenlan2003@hotmail.com
+8613819987120
Lan Chen
principal investigator · Second Affiliated Hospital, School of Medicine, Zhejiang University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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