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

Not Applicable

Recruiting

• Conditions: Heat Stroke
• Interventions: Drug: Normal Saline infusion and Ringer lactate infusion

• Registration Number: NCT05921695
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-23
• Study Start: 2023-05-28
• Study First Submitted QC: 2023-06-18
• Last Update Submitted: 2023-06-18
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27
• Primary Completion: 2025-10
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ringer lactate infusion group	Normal Saline infusion and Ringer lactate infusion	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.
Normal Saline infusion group	Normal Saline infusion and Ringer lactate infusion	During the emergency department, the normal saline infusion was not restricted.

Primary Outcome Measures

Name	Time	Method
Acute kidney injury	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

Name	Time	Method
length of ICU stay	up to 90 days	The length patient stay in ICU
in-hospital mortality	up to 90 days	number of participants dead in hospital
Continuous renal replacement therapy	up to 90 days	number of participants need continuous renal replacement therapy

Trial Locations

Locations (7)

YongKang First People's Hospital; 🇨🇳 Yongkang, Zhejiang, China

Yiwu Central Hospital; 🇨🇳 Yiwu, Zhejiang, China

Dongyang People's Hospital; 🇨🇳 Dongyang, China

The Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, China

Jinhua Municipal Central Hospital; 🇨🇳 Jinhua, China

Jinhua People's Hospital; 🇨🇳 Jinhua, China

Lanxi People's Hospital; 🇨🇳 Lanxi, China