Heat StrokeNCT05921695
The Relationship Between Normal Saline Infusion and Acute Kidney Injury in Heat Stroke
A study testing Normal Saline infusion and Ringer lactate infusion in people with Heat Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 7 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heat Stroke
- What is being tested?
- Normal Saline infusion and Ringer lactate infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 7 sitesChina
- Study dates
- 28 May 2023to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years
- diagnosed as heat stroke
- Informed consent from patients or family members.
Who cannot join
- need immediate cardiopulmonary resuscitation
- transferred from another hospital
- with original end-stage renal disease or dialysis
- with severe organ damage
- pregnant women
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Dongyang People's Hospital
Dongyang
YongKang First People's Hospital
Guli, Zhejiang, 321300
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, 310000
Jinhua Municipal Central Hospital
Jinhua
Jinhua People's Hospital
Jinhua
Lanxi People's Hospital
Lanxi
Yiwu Central Hospital
Yiwu, Zhejiang
About this study
Official title: The Relationship Between Normal Saline Infusion and Acute Kidney Injury in Patients With Heat Stroke
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.
- Conditions
- Heat Stroke
- Being tested
- Normal Saline infusion and Ringer lactate infusion
- Keywords
- heat stroke, normal saline, acute kidney injury, mortality
- Medical subject headings
- Heat Stroke, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline infusion and Ringer lactate infusionDrug
Also called NS and Lactated Ringer's solution
The heat stroke patients will be infused with different chlorine concentrations fluid during the emergency department.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline infusion group | Active comparator | During the emergency department, the normal saline infusion was not restricted. Receives: Drug: Normal Saline infusion and Ringer lactate infusion |
| Ringer lactate infusion group | Experimental | 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. Receives: Drug: Normal Saline infusion and Ringer lactate infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 90 days
Secondary outcomes (3)
Continuous renal replacement therapy
number of participants need continuous renal replacement therapy
Measured: up to 90 days
length of ICU stay
The length patient stay in ICU
Measured: up to 90 days
in-hospital mortality
number of participants dead in hospital
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start28 May 2023
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Why it stopped: Terminated due to protocol amendment: intervention window changed from entire ED stay to first 2h after ED admission. Revised protocol will be registered separately.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StrokeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Yiwu Central Hospital, Jinhua People's Hospital, Jinhua Municipal Central Hospital, Dongyang People's Hospital, Lanxi People's Hospital
- Responsible party
- Sponsor
- Investigators
- Lan Chen, PHD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921695
- Sponsor's protocol ID
- 20230506
- Status last verified
- Jun 2026
- First submitted
- 23 May 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Normal Saline Infusion and Acute Kidney Injury in Patients With Heat Stroke
- ClinicalTrials.gov ID
- NCT05921695
- Acronym / sponsor ID
- 20230506
- Conditions
- Heat Stroke
- Keywords
- heat stroke, normal saline, acute kidney injury, mortality
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to protocol amendment: intervention window changed from entire ED stay to first 2h after ED admission. Revised protocol will be registered separately.
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Yiwu Central Hospital, Jinhua People's Hospital, Jinhua Municipal Central Hospital, Dongyang People's Hospital, Lanxi People's Hospital
- Study start
- 28 May 2023 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline infusion group | Active comparator | Drug: Normal Saline infusion and Ringer lactate infusionDuring the emergency department, the normal saline infusion was not restricted. |
| Ringer lactate infusion group | Experimental | Drug: Normal Saline infusion and Ringer lactate infusionUse 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years
- diagnosed as heat stroke
- Informed consent from patients or family members.
Key exclusion criteria (5 listed)
- need immediate cardiopulmonary resuscitation
- transferred from another hospital
- with original end-stage renal disease or dialysis
- with severe organ damage
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Saline infusion and Ringer lactate infusionAlso: NS and Lactated Ringer's solutionThe heat stroke patients will be infused with different chlorine concentrations fluid during the emergency department. | Drug | Normal Saline infusion group, Ringer lactate infusion group |
Primary outcome
Acute kidney injury
Time frame: 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
3 secondary outcomes
Continuous renal replacement therapy
Time frame: up to 90 days
length of ICU stay
Time frame: up to 90 days
in-hospital mortality
Time frame: up to 90 days
Results and safety
The study was stopped early (reason given: Terminated due to protocol amendment: intervention window changed from entire ED stay to first 2h after ED admission. Revised protocol will be registered separately.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lan Chen, PHD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Saline infusion and Ringer lactate infusion in people with Heat Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated due to protocol amendment: intervention window changed from entire ED stay to first 2h after ED admission. Revised protocol will be registered separately.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury (time frame: up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.