跳至主要内容
临床试验/NCT05921695
NCT05921695终止不适用

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

Second Affiliated Hospital, School of Medicine, Zhejiang University9 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2023年5月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
发起方
入组人数
104
试验地点
9
主要终点
Acute kidney injury

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • need immediate cardiopulmonary resuscitation
  • transferred from another hospital
  • with original end-stage renal disease or dialysis
  • with severe organ damage
  • pregnant women

研究组 & 干预措施

Normal Saline infusion group

Active Comparator

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

干预措施: Normal Saline infusion and Ringer lactate infusion (Drug)

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.

干预措施: Normal Saline infusion and Ringer lactate infusion (Drug)

结局指标

主要结局

Acute kidney injury

时间窗: 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

次要结局

  • in-hospital mortality(up to 90 days)
  • Continuous renal replacement therapy(up to 90 days)
  • length of ICU stay(up to 90 days)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (9)

Loading locations...

相似试验

The Relationship Between Normal Saline Infusion and... | 临床试验