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

Study Overview
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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.

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

Conditions
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Heat Stroke

Intervention / Treatment
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* Drug: Normal Saline infusion and Ringer lactate infusion


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heat stroke, normal saline, acute kidney injury, mortality