Early Body Temperature Targets and Relationship With Prog... | NCT05921682

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

NCT05921682

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Recruiting

Last Update Posted

Sep 20, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Heat Stroke

Interventions

observation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 28, 2023Actual

Primary Completion Date

Oct 2025Estimated

Completion Date

Mar 2026Estimated

First Submitted Date

May 23, 2023

First Submission Date that Met QC Criteria

Jun 18, 2023

First Posted Date

Jun 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2024

Last Update Posted Date

Sep 20, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityOTHER

Collaborators

Name	Class
Yiwu Central Hospital	OTHER
Jinhua People's Hospital	OTHER
Jinhua Municipal Central Hospital	OTHER
Dongyang People's Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with heat stroke		Patients with heat stroke presenting to the emergency department at the study site	Other: observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observation	Other	This study is an observational study. Patients will receive conventional cooling measures and organ function support.	Patients with heat stroke

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
continuous renal replacement therapy	Number of participants who need CRRT	up to 90 days
length of ICU stay	The length patient stay in ICU

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Comprehensive tertiary hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiuqin Feng	Contact	+8613757119151		fengxiuqin@zju.edu.cn
Lan Chen	Contact	+8613819987120		jhchenlan2003@hotmail.com

Overall Officials

Name	Affiliation	Role
Lan Chen	Second Affiliated Hospital, School of Medicine, Zhejiang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yiwu Central Hospital	Recruiting	Yiwu	Zhejiang		China

Condition Browse Module

MeSH Terms

ID	Term
D018883	Heat Stroke

Ancestor Terms

ID	Term
D018882	Heat Stress Disorders
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided