The Relationship Between Normal Saline Infusion and Acute Kidney Injury in Heat Stroke

NCT ID: NCT05921695

Last Updated: 2024-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-28

Study Completion Date

2026-03-31

Brief Summary

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The goal of this clinical trial is to compare the effect of high chlorine solution such as normal saline and non-high chlorine solution such as sodium lactate ringer's solution on renal function in patients with heat stroke. The main question it aims to answer is whether limiting the amount of normal saline infusion during emergency department can lower the incidence of acute kidney injury and mortality in patients with heat stroke.

Participants will receive a free normal saline infusion during the emergency department according to the study design, or a restricted normal saline infusion while using sodium lactate Ringer's instead.

Researchers will compare the normal saline infusion group and sodium lactate Ringer's group to see if limiting the amount of normal saline infusion during emergency department can lower the incidence of acute kidney injury and mortality in patients with heat stroke.

Detailed Description

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Conditions

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Heat Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Normal Saline infusion group

During the emergency department, the normal saline infusion was not restricted.

Group Type ACTIVE_COMPARATOR

Normal Saline infusion and Ringer lactate infusion

Intervention Type DRUG

The heat stroke patients will be infused with different chlorine concentrations fluid during the emergency department.

Ringer lactate infusion group

Use ringer lactate or other balanced crystallographic solution instead of normal saline. Strictly limit the amount of normal saline infusion. Normal saline will only be infused by medical advice if the patient has hypochloremia or needs saline as solvent.

Group Type EXPERIMENTAL

Normal Saline infusion and Ringer lactate infusion

Intervention Type DRUG

The heat stroke patients will be infused with different chlorine concentrations fluid during the emergency department.

Interventions

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Normal Saline infusion and Ringer lactate infusion

The heat stroke patients will be infused with different chlorine concentrations fluid during the emergency department.

Intervention Type DRUG

Other Intervention Names

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NS and Lactated Ringer's solution

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years
* diagnosed as heat stroke
* Informed consent from patients or family members.

Exclusion Criteria

* need immediate cardiopulmonary resuscitation
* transferred from another hospital
* with original end-stage renal disease or dialysis
* with severe organ damage
* pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yiwu Central Hospital

OTHER

Sponsor Role collaborator

Jinhua People's Hospital

OTHER

Sponsor Role collaborator

Jinhua Municipal Central Hospital

OTHER

Sponsor Role collaborator

Dongyang People's Hospital

OTHER

Sponsor Role collaborator

Lanxi People's Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lan Chen, PHD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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YongKang First People's Hospital

Guli, Zhejiang, China

Site Status RECRUITING

Yiwu Central Hospital

Yiwu, Zhejiang, China

Site Status RECRUITING

Dongyang People's Hospital

Dongyang, , China

Site Status RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, , China

Site Status RECRUITING

Jinhua Municipal Central Hospital

Jinhua, , China

Site Status RECRUITING

Jinhua People's Hospital

Jinhua, , China

Site Status RECRUITING

Lanxi People's Hospital

Lanxi, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiuqin Feng, PRO

Role: CONTACT

8613757119151

Lan Chen, PHD

Role: CONTACT

+8613819987120

Facility Contacts

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Huimin Ma

Role: primary

8605797111834

Zhumei Gong

Role: primary

Shuying Xu

Role: primary

Xiuqin Feng

Role: primary

+8613757119151

Lan Chen

Role: backup

+8613819987120

Sunying Wu

Role: primary

Liyun Lu

Role: primary

Xiaoling Yang

Role: primary

Other Identifiers

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20230506

Identifier Type: -

Identifier Source: org_study_id

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