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

Primary Purpose

Heat Stroke

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Normal Saline infusion and Ringer lactate infusion
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heat Stroke focused on measuring heat stroke, normal saline, acute kidney injury, mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yiwu Central HospitalRecruiting
  • Dongyang People's HospitalRecruiting
  • The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
  • Jinhua Municipal Central HospitalRecruiting
  • Jinhua People's HospitalRecruiting
  • Lanxi People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Normal Saline infusion group

Ringer lactate infusion group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Continuous renal replacement therapy
number of participants need continuous renal replacement therapy
length of ICU stay
The length patient stay in ICU
in-hospital mortality
number of participants dead in hospital

Full Information

First Posted
May 23, 2023
Last Updated
June 18, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Yiwu Central Hospital, Jinhua People's Hospital, Jinhua Municipal Central Hospital, Dongyang People's Hospital, Lanxi People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05921695
Brief Title
The Relationship Between Normal Saline Infusion and Acute Kidney Injury in Heat Stroke
Official Title
The Relationship Between Normal Saline Infusion and Acute Kidney Injury in Patients With Heat Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2023 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Yiwu Central Hospital, Jinhua People's Hospital, Jinhua Municipal Central Hospital, Dongyang People's Hospital, Lanxi People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heat Stroke
Keywords
heat stroke, normal saline, acute kidney injury, mortality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal Saline infusion group
Arm Type
Active Comparator
Arm Description
During the emergency department, the normal saline infusion was not restricted.
Arm Title
Ringer lactate infusion group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal Saline infusion and Ringer lactate infusion
Other Intervention Name(s)
NS and Lactated Ringer's solution
Intervention Description
The heat stroke patients will be infused with different chlorine concentrations fluid during the emergency department.
Primary Outcome Measure Information:
Title
Acute kidney injury
Description
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 Outcome Measure Information:
Title
Continuous renal replacement therapy
Description
number of participants need continuous renal replacement therapy
Time Frame
up to 90 days
Title
length of ICU stay
Description
The length patient stay in ICU
Time Frame
up to 90 days
Title
in-hospital mortality
Description
number of participants dead in hospital
Time Frame
up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuqin Feng, PRO
Phone
8613757119151
Email
fengxiuqin@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lan Chen, PHD
Phone
+8613819987120
Email
jhchenlan2003@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lan Chen, PHD
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yiwu Central Hospital
City
Yiwu
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhumei Gong
Email
179219712@qq.com
Facility Name
Dongyang People's Hospital
City
Dongyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuying Xu
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuqin Feng
Phone
+8613757119151
Email
fengxiuqin@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Lan Chen
Phone
+8613819987120
Email
jhchenlan2003@hotmail.com
Facility Name
Jinhua Municipal Central Hospital
City
Jinhua
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunying Wu
Facility Name
Jinhua People's Hospital
City
Jinhua
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liyun Lu
Email
779676709@qq.com
Facility Name
Lanxi People's Hospital
City
Lanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoling Yang

12. IPD Sharing Statement

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

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