NCT05921682

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

May 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

2.3 years

First QC Date

May 23, 2023

Last Update Submit

September 18, 2024

Conditions

Keywords

heat stroke, body temperature, outcomes

Outcome Measures

Primary Outcomes (2)

  • mortality

    Number of participants who dead during hospitalization

    up to 90 days

  • organ damage

    Number of participants with organ damage, including but not limited to brain, lung, heart, kidney, liver and coagulation

    up to 90 days

Secondary Outcomes (3)

  • continuous renal replacement therapy

    up to 90 days

  • length of ICU stay

    up to 90 days

  • length of hospital stay

    up to 90 days

Study Arms (1)

Patients with heat stroke

Patients with heat stroke presenting to the emergency department at the study site

Other: observation

Interventions

This study is an observational study. Patients will receive conventional cooling measures and organ function support.

Patients with heat stroke

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Comprehensive tertiary hospital

You may qualify if:

  • ≥ 18 years; ② diagnosed as heat stroke; ③ Informed consent from patients or family members.

You may not qualify if:

  • need immediate cardiopulmonary resuscitation; ② transferred from another hospital; ③ with severe underlying organ insufficiency; ④ pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Yiwu Central Hospital

Yiwu, Zhejiang, China

RECRUITING

Dongyang People's Hospital

Dongyang, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, 310000, China

RECRUITING

Jinhua Municipal Central Hospital

Jinhua, China

RECRUITING

Jinhua People's Hospital

Jinhua, China

RECRUITING

Lanxi People's Hospital

Lanxi, China

RECRUITING

MeSH Terms

Conditions

Heat Stroke

Interventions

Observation

Condition Hierarchy (Ancestors)

Heat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Lan Chen

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 27, 2023

Study Start

May 28, 2023

Primary Completion

October 1, 2025

Study Completion

March 1, 2026

Last Updated

September 20, 2024

Record last verified: 2024-09

Locations