Health TrialsbyHealthPanel

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

ConditionHeat Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years old

diagnosed as heat stroke

informed consent of patients or family members

Disqualifiers

need immediate cardiopulmonary resuscitation

body temperature <39.5℃ on admission

with the underlying disease of severe organ damage

pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: non-cooling blanket groupExperimental treatment 1 intervention
Group B: Cooling blanket groupActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Yiwu Central Hospital

Collaborator

Jinhua Municipal Central Hospital

Collaborator

Jinhua People's Hospital

Collaborator

Lanxi People's Hospital

Collaborator

Yongkang No.1 People' s Hospital

Collaborator

Dongyang People's Hospital

Collaborator

Source ClinicalTrials.gov
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