Heat StrokeNCT05921682
Early Body Temperature Targets and Relationship With Prognosis in Patients With Heat Stroke
An observational study of Heat Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heat Stroke
- What is being tested?
- observation
- How many people
- 100 participants
- Where
- 6 sitesChina
- Study dates
- 28 May 2023to Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Comprehensive tertiary hospital
Who may be able to join
- ≥ 18 years; ② diagnosed as heat stroke; ③ Informed consent from patients or family members.
Who cannot join
- need immediate cardiopulmonary resuscitation; ② transferred from another hospital; ③ with severe underlying organ insufficiency; ④ pregnant women.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Dongyang People's Hospital
Dongyang
Shuying Xu
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, 310000
Xiuqin Feng, +8613757119151, fengxiuqin@zju.edu.cn
Lan Chen, +8613819987120, jhchenlan2003@hotmail.com
- Recruiting
Jinhua Municipal Central Hospital
Jinhua
Sunying Wu
- Recruiting
Jinhua People's Hospital
Jinhua
Liyun Lu, 779676709@qq.com
- Recruiting
Lanxi People's Hospital
Lanxi
Xiaoling Yang
- Recruiting
Yiwu Central Hospital
Yiwu, Zhejiang
Zhumei Gong, 179219712@qq.com
About this study
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.
- Conditions
- Heat Stroke
- Being tested
- observation
- Keywords
- heat stroke, body temperature, outcomes
- Medical subject headings
- Heat Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
This study is an observational study. Patients will receive conventional cooling measures and organ function support.
| Study group | Role | What they receive |
|---|---|---|
| Patients with heat stroke | Patients with heat stroke presenting to the emergency department at the study site Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Number of participants who dead during hospitalization
Measured: up to 90 days
organ damage
Number of participants with organ damage, including but not limited to brain, lung, heart, kidney, liver and coagulation
Measured: up to 90 days
Secondary outcomes (3)
continuous renal replacement therapy
Number of participants who need CRRT
Measured: up to 90 days
length of ICU stay
The length patient stay in ICU
Measured: up to 90 days
length of hospital stay
The length patient stay in hospital
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start28 May 2023
- Primary completionOct 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StrokeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Yiwu Central Hospital, Jinhua People's Hospital, Jinhua Municipal Central Hospital, Dongyang People's Hospital, Lanxi People's Hospital
- Responsible party
- Sponsor
- Investigators
- Lan Chen, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921682
- Sponsor's protocol ID
- 2023-0517
- Status last verified
- Sep 2024
- First submitted
- 23 May 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Body Temperature Targets and Relationship With Prognosis in Patients With Heat Stroke
- ClinicalTrials.gov ID
- NCT05921682
- Acronym / sponsor ID
- 2023-0517
- Conditions
- Heat Stroke
- Keywords
- heat stroke, body temperature, outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Yiwu Central Hospital, Jinhua People's Hospital, Jinhua Municipal Central Hospital, Dongyang People's Hospital, Lanxi People's Hospital
- Study start
- 28 May 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with heat stroke | – | Other: observationPatients with heat stroke presenting to the emergency department at the study site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Comprehensive tertiary hospital
Key inclusion criteria (1 listed)
- ≥ 18 years; ② diagnosed as heat stroke; ③ Informed consent from patients or family members.
Key exclusion criteria (1 listed)
- need immediate cardiopulmonary resuscitation; ② transferred from another hospital; ③ with severe underlying organ insufficiency; ④ pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationThis study is an observational study. Patients will receive conventional cooling measures and organ function support. | Other | Patients with heat stroke |
Primary outcome
mortality
Time frame: up to 90 days
Number of participants who dead during hospitalization
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
3 secondary outcomes
continuous renal replacement therapy
Time frame: up to 90 days
length of ICU stay
Time frame: up to 90 days
length of hospital stay
Time frame: up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
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Heat Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lan Chen principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heat Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuqin Feng (+8613757119151, fengxiuqin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: up to 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.