Early Body Temperature Targets and Relationship With Prognosis in Patients With Heat Stroke
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ClinicalTrials.gov Identifier: NCT05921682 |
Recruitment Status :
Recruiting
First Posted : June 27, 2023
Last Update Posted : June 27, 2023
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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.
Condition or disease | Intervention/treatment |
---|---|
Heat Stroke | Other: observation |
Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Early Body Temperature Targets and Relationship With Prognosis in Patients With Heat Stroke |
Actual Study Start Date : | May 28, 2023 |
Estimated Primary Completion Date : | October 2025 |
Estimated Study Completion Date : | March 2026 |
Group/Cohort | Intervention/treatment |
---|---|
Patients with heat stroke
Patients with heat stroke presenting to the emergency department at the study site
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Other: observation
This study is an observational study. Patients will receive conventional cooling measures and organ function support. |
- 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
- continuous renal replacement therapy [ Time Frame: up to 90 days ]Number of participants who need CRRT
- length of ICU stay [ Time Frame: up to 90 days ]The length patient stay in ICU
- length of hospital stay [ Time Frame: up to 90 days ]The length patient stay in hospital
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- ≥ 18 years; ② diagnosed as heat stroke; ③ Informed consent from patients or family members.
Exclusion Criteria:
- need immediate cardiopulmonary resuscitation; ② transferred from another hospital; ③ with severe underlying organ insufficiency; ④ pregnant women.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05921682
Contact: Xiuqin Feng | +8613757119151 | fengxiuqin@zju.edu.cn | |
Contact: Lan Chen | +8613819987120 | jhchenlan2003@hotmail.com |
China, Zhejiang | |
Yiwu Central Hospital | Recruiting |
Yiwu, Zhejiang, China | |
Contact: Zhumei Gong 179219712@qq.com | |
China | |
Dongyang People's Hospital | Recruiting |
Dongyang, China | |
Contact: Shuying Xu | |
The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting |
Hangzhou, China, 310000 | |
Contact: Xiuqin Feng +8613757119151 fengxiuqin@zju.edu.cn | |
Contact: Lan Chen +8613819987120 jhchenlan2003@hotmail.com | |
Jinhua Municipal Central Hospital | Recruiting |
Jinhua, China | |
Contact: Sunying Wu | |
Jinhua People's Hospital | Recruiting |
Jinhua, China | |
Contact: Liyun Lu 779676709@qq.com | |
Lanxi People's Hospital | Recruiting |
Lanxi, China | |
Contact: Xiaoling Yang |
Principal Investigator: | Lan Chen | Second Affiliated Hospital, School of Medicine, Zhejiang University |
Responsible Party: | Second Affiliated Hospital, School of Medicine, Zhejiang University |
ClinicalTrials.gov Identifier: | NCT05921682 |
Other Study ID Numbers: |
2023-0517 |
First Posted: | June 27, 2023 Key Record Dates |
Last Update Posted: | June 27, 2023 |
Last Verified: | May 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
heat stroke, body temperature, outcomes |
Stroke Heat Stroke Sunstroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Heat Stress Disorders Wounds and Injuries |