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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
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

Tracking Information
First Submitted Date May 23, 2023
First Posted Date June 27, 2023
Last Update Posted Date June 27, 2023
Actual Study Start Date May 28, 2023
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2023)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 18, 2023)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Body Temperature Targets and Relationship With Prognosis in Patients With Heat Stroke
Official Title Early Body Temperature Targets and Relationship With Prognosis in Patients With Heat Stroke
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Comprehensive tertiary hospital
Condition Heat Stroke
Intervention Other: observation
This study is an observational study. Patients will receive conventional cooling measures and organ function support.
Study Groups/Cohorts Patients with heat stroke
Patients with heat stroke presenting to the emergency department at the study site
Intervention: Other: observation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 18, 2023)		 200
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2026
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Xiuqin Feng +8613757119151 fengxiuqin@zju.edu.cn
Contact: Lan Chen +8613819987120 jhchenlan2003@hotmail.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT05921682
Other Study ID Numbers 2023-0517
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Original Responsible Party Same as current
Current Study Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Original Study Sponsor Same as current
Collaborators
  • Yiwu Central Hospital
  • Jinhua People's Hospital
  • Jinhua Municipal Central Hospital
  • Dongyang People's Hospital
  • Lanxi People's Hospital
Investigators
Principal Investigator: Lan Chen Second Affiliated Hospital, School of Medicine, Zhejiang University
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date May 2023