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

Heat Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921695
• Other study ID #: 20230506
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2023
• Est. completion date: March 2026

Study information

• Verified date: May 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xiuqin Feng, PRO
• Phone: 8613757119151
• Email: fengxiuqin[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: March 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Heat Stroke
• Stroke

Intervention

Drug:
• Normal Saline infusion and Ringer lactate infusion
The heat stroke patients will be infused with different chlorine concentrations fluid during the emergency department.

Locations

Country	Name	City	State
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	Yiwu Central Hospital	Yiwu	Zhejiang

Sponsors (6)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Dongyang People's Hospital, Jinhua Municipal Central Hospital, Jinhua People's Hospital, Lanxi People's Hospital, Yiwu Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Continuous renal replacement therapy	number of participants need continuous renal replacement therapy	up to 90 days
Secondary	length of ICU stay	The length patient stay in ICU	up to 90 days
Secondary	in-hospital mortality	number of participants dead in hospital	up to 90 days