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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05921695
Recruitment Status : Recruiting
First Posted : June 27, 2023
Last Update Posted : June 27, 2023
Sponsor:
Collaborators:
Yiwu Central Hospital
Jinhua People's Hospital
Jinhua Municipal Central Hospital
Dongyang People's Hospital
Lanxi People's Hospital
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Heat Stroke Drug: Normal Saline infusion and Ringer lactate infusion Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Relationship Between Normal Saline Infusion and Acute Kidney Injury in Patients With Heat Stroke
Actual Study Start Date : May 28, 2023
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: NS and Lactated Ringer's solution


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Continuous renal replacement therapy [ Time Frame: up to 90 days ]
    number of participants need continuous renal replacement therapy

  2. length of ICU stay [ Time Frame: up to 90 days ]
    The length patient stay in ICU

  3. in-hospital mortality [ Time Frame: up to 90 days ]
    number of participants dead in hospital


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05921695


Contacts
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Contact: Xiuqin Feng, PRO 8613757119151 fengxiuqin@zju.edu.cn
Contact: Lan Chen, PHD +8613819987120 jhchenlan2003@hotmail.com

Locations
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China, Zhejiang
Yiwu Central Hospital Recruiting
Yiwu, Zhejiang, China
Contact: Zhumei Gong       179219712@qq.com   
China
Dongyang People's Hospital Recruiting
Dongyang, China
Contact: Shuying Xu         
The Second Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, China, 310000
Contact: Xiuqin Feng    +8613757119151    fengxiuqin@zju.edu.cn   
Contact: Lan Chen    +8613819987120    jhchenlan2003@hotmail.com   
Jinhua Municipal Central Hospital Recruiting
Jinhua, China
Contact: Sunying Wu         
Jinhua People's Hospital Recruiting
Jinhua, China
Contact: Liyun Lu       779676709@qq.com   
Lanxi People's Hospital Recruiting
Lanxi, China
Contact: Xiaoling Yang         
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Yiwu Central Hospital
Jinhua People's Hospital
Jinhua Municipal Central Hospital
Dongyang People's Hospital
Lanxi People's Hospital
Investigators
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Principal Investigator: Lan Chen, PHD Second Affiliated Hospital, School of Medicine, Zhejiang University
More Information
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT05921695    
Other Study ID Numbers: 20230506
First Posted: June 27, 2023    Key Record Dates
Last Update Posted: June 27, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
heat stroke
normal saline
acute kidney injury
mortality
Additional relevant MeSH terms:
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Stroke
Acute Kidney Injury
Heat Stroke
Sunstroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Renal Insufficiency
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Heat Stress Disorders
Wounds and Injuries