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Terminated due to protocol amendment: intervention window changed from entire ED stay to first 2h after ED admission. Revised protocol will be registered separately.
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| Name | Class |
|---|---|
| Yiwu Central Hospital | OTHER |
| Jinhua People's Hospital | OTHER |
| Jinhua Municipal Central Hospital | OTHER |
| Dongyang People's Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline infusion group | Active Comparator | During the emergency department, the normal saline infusion was not restricted. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Saline infusion and Ringer lactate infusion | Drug | The heat stroke patients will be infused with different chlorine concentrations fluid during the emergency department. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous renal replacement therapy | number of participants need continuous renal replacement therapy | up to 90 days |
| length of ICU stay | The length patient stay in ICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lan Chen, PHD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| YongKang First People's Hospital | Guli | Zhejiang | 321300 | China | ||
| Yiwu Central Hospital |
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| ID | Term |
|---|---|
| D018883 | Heat Stroke |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| OTHER |
| Lanxi People's Hospital | OTHER |
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|
| up to 90 days |
| in-hospital mortality | number of participants dead in hospital | up to 90 days |
| 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 |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |