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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05921682
Recruitment Status : Recruiting
First Posted : June 27, 2023
Last Update Posted : June 27, 2023
Sponsor:
Collaborators:
Yiwu Central Hospital
Jinhua People's Hospital
Jinhua Municipal Central Hospital
Dongyang People's Hospital
Lanxi People's Hospital
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Heat Stroke Other: observation

Study Design
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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
Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with heat stroke
Patients with heat stroke presenting to the emergency department at the study site
 Other: observation
This study is an observational study. Patients will receive conventional cooling measures and organ function support.


Outcome Measures
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Primary Outcome Measures :
  1. mortality [ Time Frame: up to 90 days ]
    Number of participants who dead during hospitalization

  2. 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


Secondary Outcome Measures :
  1. continuous renal replacement therapy [ Time Frame: up to 90 days ]
    Number of participants who need CRRT

  2. length of ICU stay [ Time Frame: up to 90 days ]
    The length patient stay in ICU

  3. length of hospital stay [ Time Frame: up to 90 days ]
    The length patient stay in hospital


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Comprehensive tertiary hospital
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Xiuqin Feng +8613757119151 fengxiuqin@zju.edu.cn
Contact: Lan Chen +8613819987120 jhchenlan2003@hotmail.com

Locations
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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         
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Yiwu Central Hospital
Jinhua People's Hospital
Jinhua Municipal Central Hospital
Dongyang People's Hospital
Lanxi People's Hospital
Investigators
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Principal Investigator: Lan Chen Second Affiliated Hospital, School of Medicine, Zhejiang University
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
heat stroke, body temperature, outcomes
Additional relevant MeSH terms:
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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