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

June 18, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Dongyang, China
        • Recruiting
        • Dongyang People's Hospital
        • Contact:
          • Shuying Xu
      • Hangzhou, China, 310000
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
        • Contact:
      • Jinhua, China
        • Recruiting
        • Jinhua municipal central hospital
        • Contact:
          • Sunying Wu
      • Jinhua, China
      • Lanxi, China
        • Recruiting
        • Lanxi People's Hospital
        • Contact:
          • Xiaoling Yang
    • Zhejiang
      • Yiwu, Zhejiang, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Normal Saline infusion group
During the emergency department, the normal saline infusion was not restricted.
Drug: Normal Saline infusion and Ringer lactate infusion
The heat stroke patients will be infused with different chlorine concentrations fluid during the emergency department.
Other Names:
  • NS and Lactated Ringer's solution
Experimental: 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.
Drug: Normal Saline infusion and Ringer lactate infusion
The heat stroke patients will be infused with different chlorine concentrations fluid during the emergency department.
Other Names:
  • NS and Lactated Ringer's solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury
Time Frame: up to 90 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous renal replacement therapy
Time Frame: up to 90 days
number of participants need continuous renal replacement therapy
up to 90 days
length of ICU stay
Time Frame: up to 90 days
The length patient stay in ICU
up to 90 days
in-hospital mortality
Time Frame: up to 90 days
number of participants dead in hospital
up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Jinhua People's Hospital
Jinhua Municipal Central Hospital
Yiwu Central Hospital
Dongyang People's Hospital
Lanxi People's Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

June 18, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230506

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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