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TerminatedNCT05921695Updated Jun 4, 2026

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

An interventional study of Normal Saline infusion and Ringer lactate infusion in Heat Stroke, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Terminated at 7 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Supportive care

Why this study was terminated
Terminated due to protocol amendment: intervention window changed from entire ED stay to first 2h after ED admission. Revised protocol will be registered separately.
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heat Stroke

Keywords

  • heat stroke
  • normal saline
  • acute kidney injury
  • mortality
03

In context

Heat Stroke

21 studies on the registry are indexed under Heat Stroke; 10 are open to participants now.

This study's enrollment of 104 is above the median of 34 across 13 interventional studies indexed under Heat Stroke.

Browse Heat Stroke studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥ 18 years
  • diagnosed as heat stroke
  • from patients or family members.

Exclusion criteria

Exclusion Criteria:

  • need immediate cardiopulmonary resuscitation
  • transferred from another hospital
  • with original end-stage renal disease or dialysis
  • with severe organ damage
  • pregnant women
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
104 participants (actual)

Study arms

  • Active comparator
    Normal Saline infusion group

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

    Drug: Normal Saline infusion and Ringer lactate infusion

  • Experimental
    Ringer lactate infusion group

    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

Interventions

  • DrugNormal Saline infusion and Ringer lactate infusion

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

    Also known as: NS and Lactated Ringer's solution

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 90 days

Secondary outcomes

  1. Continuous renal replacement therapy

    number of participants need continuous renal replacement therapy

    Time frame: up to 90 days

  2. length of ICU stay

    The length patient stay in ICU

    Time frame: up to 90 days

  3. in-hospital mortality

    number of participants dead in hospital

    Time frame: up to 90 days

07

Study locations

7 sites
  • YongKang First People's Hospital
    Guli, Zhejiang 321300, China
  • Yiwu Central Hospital
    Yiwu, Zhejiang, China
  • Dongyang People's Hospital
    Dongyang, China
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
    Hangzhou, 310000, China
  • Jinhua Municipal Central Hospital
    Jinhua, China
  • Jinhua People's Hospital
    Jinhua, China
  • Lanxi People's Hospital
    Lanxi, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05921695
Collaborators
Yiwu Central Hospital, Jinhua People's Hospital, Jinhua Municipal Central Hospital, Dongyang People's Hospital, Lanxi People's Hospital
Responsible party
Sponsor
First posted
Jun 27, 2023
Start date
May 28, 2023
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026
Last update
Jun 4, 2026

Study contacts

Lan Chen, PHD
principal investigator · Second Affiliated Hospital, School of Medicine, Zhejiang University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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