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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05921682
• Collaborator: Yiwu Central Hospital (Other), Jinhua People's Hospital (Other), Jinhua Municipal Central Hospital (Other), Dongyang People's Hospital (Other), Lanxi People's Hospital (Other)
• Enrollment: 200
• Locations: 6
• Anticipated Duration (Months): 33.1
• Patients Per Site: 33.3
• Patients Per Site Per Month: 1

Study Details

Study Description

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	Phase
Heat Stroke	Other: observation

Study Design

• Study Type: Observational
• Anticipated 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
• Anticipated Primary Completion Date: Oct 1, 2025
• Anticipated Study Completion Date: Mar 1, 2026

Arms and Interventions

Arm	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

Primary Outcome Measures

1. mortality [up to 90 days]

   Number of participants who dead during hospitalization

2. organ damage [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 [up to 90 days]

   Number of participants who need CRRT

2. length of ICU stay [up to 90 days]

   The length patient stay in ICU

3. length of hospital stay [up to 90 days]

   The length patient stay in hospital

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Yiwu Central Hospital	Yiwu	Zhejiang	China
2	Dongyang People's Hospital	Dongyang		China
3	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou		China	310000
4	Jinhua Municipal Central Hospital	Jinhua		China
5	Jinhua People's Hospital	Jinhua		China
6	Lanxi People's Hospital	Lanxi		China

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

• Principal Investigator: Lan Chen, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT05921682
• Other Study ID Numbers: 2023-0517
• First Posted: Jun 27, 2023
• Last Update Posted: Jun 27, 2023
• Last Verified: May 1, 2023

• 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: Stroke; Heat Stroke; Sunstroke

Study Results

No Results Posted as of Jun 27, 2023