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

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ClinicalTrials.gov Identifier: NCT05921695
Recruitment Status : Recruiting
First Posted : June 27, 2023
Last Update Posted : June 27, 2023
Sponsor:
Collaborators:
Yiwu Central Hospital
Jinhua People's Hospital
Jinhua Municipal Central Hospital
Dongyang People's Hospital
Lanxi People's Hospital
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Tracking Information
First Submitted Date  ICMJE May 23, 2023
First Posted Date  ICMJE June 27, 2023
Last Update Posted Date June 27, 2023
Actual Study Start Date  ICMJE May 28, 2023
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2023)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2023)
  • Continuous renal replacement therapy [ Time Frame: up to 90 days ]
    number of participants need continuous renal replacement therapy
  • length of ICU stay [ Time Frame: up to 90 days ]
    The length patient stay in ICU
  • in-hospital mortality [ Time Frame: up to 90 days ]
    number of participants dead in hospital
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Relationship Between Normal Saline Infusion and Acute Kidney Injury in Heat Stroke
Official Title  ICMJE The Relationship Between Normal Saline Infusion and Acute Kidney Injury in Patients With Heat Stroke
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Heat Stroke
Intervention  ICMJE Drug: Normal Saline infusion and Ringer lactate infusion
The heat stroke patients will be infused with different chlorine concentrations fluid during the emergency department.
Other Name: NS and Lactated Ringer's solution
Study Arms  ICMJE
  • Active Comparator: Normal Saline infusion group
    During the emergency department, the normal saline infusion was not restricted.
    Intervention: 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.
    Intervention: Drug: Normal Saline infusion and Ringer lactate infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2023)		 190
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2026
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiuqin Feng, PRO 8613757119151 fengxiuqin@zju.edu.cn
Contact: Lan Chen, PHD +8613819987120 jhchenlan2003@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05921695
Other Study ID Numbers  ICMJE 20230506
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Second Affiliated Hospital, School of Medicine, Zhejiang University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Yiwu Central Hospital
  • Jinhua People's Hospital
  • Jinhua Municipal Central Hospital
  • Dongyang People's Hospital
  • Lanxi People's Hospital
Investigators  ICMJE
Principal Investigator: Lan Chen, PHD Second Affiliated Hospital, School of Medicine, Zhejiang University
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP