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RecruitingNCT05921682Updated Sep 20, 2024

Early Body Temperature Targets and Relationship With Prognosis in Patients With Heat Stroke

An observational study in Heat Stroke, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-20.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this observational study is to explore the optimal target body temperature in first 24 hours and the relationship between body temperature and adverse outcomes of heat stroke.

The main questions it aims to answer are:

  • the optimal target body temperature at 0.5 h, 2 h, and the lowest body temperature of heat stroke.
  • the best body temperature at the cutting point of stop cooling.
  • The relationship between the volume and speed of ice saline infusion and the cooling effect.
02

Conditions studied

  • Heat Stroke

Browse trials for

Keywords

  • heat stroke, body temperature, outcomes
03

In context

Heat Stroke

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

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
Sampling method
Non-probability sample

Study population

Comprehensive tertiary hospital

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; ② diagnosed as heat stroke; ③ from patients or family members.

Exclusion criteria

Exclusion Criteria:

  • need immediate cardiopulmonary resuscitation; ② transferred from another hospital; ③ with severe underlying organ insufficiency; ④ 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

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with heat stroke

    Patients with heat stroke presenting to the emergency department at the study site

    Other: observation

Interventions

  • Otherobservation

    This study is an observational study. Patients will receive conventional cooling measures and organ function support.

06

What researchers measure

Primary outcomes

  1. mortality

    Number of participants who dead during hospitalization

    Time frame: up to 90 days

  2. organ damage

    Number of participants with organ damage, including but not limited to brain, lung, heart, kidney, liver and coagulation

    Time frame: up to 90 days

Secondary outcomes

  1. continuous renal replacement therapy

    Number of participants who need CRRT

    Time frame: up to 90 days

  2. length of ICU stay

    The length patient stay in ICU

    Time frame: up to 90 days

  3. length of hospital stay

    The length patient stay in hospital

    Time frame: up to 90 days

07

Study locations

6 of 6 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05921682
Collaborators
Yiwu Central Hospital, Jinhua People's Hospital, Jinhua Municipal Central Hospital, Dongyang People's Hospital, Lanxi People's Hospital
Responsible party
Sponsor
First posted
Jun 27, 2023
Start date
May 28, 2023
Primary completion
Oct 2025 (estimated)
Completion
Mar 2026 (estimated)
Last update
Sep 20, 2024

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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