NCT05921695

Brief Summary

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

7 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

Heat Stroke

Keywords

heat strokenormal salineacute kidney injurymortality

Outcome Measures

Primary Outcomes (1)

  • Acute kidney injury

    Acute kidney injury was defined as increase in serum creatinine by 50% within 7 days, or increase in serum creatinine by 0.3 mg/dl (26.5μmol/l) within 2 days, or oliguria

    up to 90 days

Secondary Outcomes (3)

  • Continuous renal replacement therapy

    up to 90 days

  • length of ICU stay

    up to 90 days

  • in-hospital mortality

    up to 90 days

Study Arms (2)

Normal Saline infusion group

ACTIVE COMPARATOR

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

Drug: Normal Saline infusion and Ringer lactate infusion

Ringer lactate infusion group

EXPERIMENTAL

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.

Drug: Normal Saline infusion and Ringer lactate infusion

Interventions

Normal Saline infusion and Ringer lactate infusionDRUG

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

Also known as: NS and Lactated Ringer's solution
Normal Saline infusion groupRinger lactate infusion group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

YongKang First People's Hospital

Guli, Zhejiang, 321300, China

RECRUITING

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 StrokeAcute Kidney Injury

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Heat Stress DisordersWounds and InjuriesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Lan Chen, PHD

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuqin Feng, PRO

CONTACT

8613757119151fengxiuqin@zju.edu.cn

Lan Chen, PHD

CONTACT

+8613819987120jhchenlan2003@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
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

CN(7)