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

Zhejiang University

Status: Enrolling

Conditions: Heat Stroke

Treatments: Drug: Normal Saline infusion and Ringer lactate infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05921695

20230506

Details and patient eligibility

About

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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Normal Saline infusion group

Active Comparator group

Description:

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

Treatment:

Drug: Normal Saline infusion and Ringer lactate infusion

Ringer lactate infusion group

Experimental group

Description:

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.

Treatment:

Drug: Normal Saline infusion and Ringer lactate infusion