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

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05921695
Enrollment
104
Registered
2023-06-27
Start date
2023-05-28
Completion date
2026-06-01
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heat Stroke

Keywords

heat stroke, normal saline, acute kidney injury, mortality

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.

Interventions

DRUGNormal Saline infusion and Ringer lactate infusion

The heat stroke patients will be infused with different chlorine concentrations fluid during the emergency department.

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acute kidney injuryup to 90 daysAcute 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

MeasureTime frameDescription
Continuous renal replacement therapyup to 90 daysnumber of participants need continuous renal replacement therapy
length of ICU stayup to 90 daysThe length patient stay in ICU
in-hospital mortalityup to 90 daysnumber of participants dead in hospital

Countries

China

Contacts

PRINCIPAL_INVESTIGATORLan Chen, PHD

Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026