Effects of Low-chlorine Vs High-chlorine Crystalloid Solutions in Septic Shock Adults
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 主要终点
- the composite of death and new receipt of renal-replacement therapy MAKE30
研究概览
简要总结
Fluid resuscitation is an important treatment in septic shock patients, however whether crystalloid composition affects septic shock patients outcomes remains unclear. According to previous studies, low-chlorine crystalloids could significantly reduce the incidence of kidney injury and 30-day mortality compared with high-chlorine crystalloids in critically ill adults. Therefore, we hypothesized that the use of low-chlorine crystalloids would result in a lower incidence of major adverse kidney events within 30 days (MAKE 30: overall incidence of death, new renal-replacement therapy, and persistent renal dysfunction) than high-chlorine crystalloids in septic shock adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old <age ≤ 85 years old;
- •Diagnosis of septic shock within 24 hours (sepsis 3.0);
- •Needing fluid resuscitation judged by clinicians;
- •The patient or the patient's legally acceptable representative signs the informed consent (signs within 24h of enrollment)
排除标准
- •Pregnant or lactating period;
- •Renal replacement therapy has been received or expected to receive within 6 hours;
- •Those who were previously enrolled in the study;
- •Estimated death within 24 hours;
- •Other situations that not suitable for enrollment judged by researchers.
研究组 & 干预措施
Sodium Bicarbonate Ringer's Injection
- administration route and dosage：Intravenous infusion, 500~1000 ml/time. The dosage can be increased or decreased according to the age, weight and symptoms.
- rate: according to the the routine rate of fluid resuscitation of septic shock in the ICUs of Zhongda Hospital, School of Medicine, Southeast University.
干预措施: Sodium Bicarbonate Ringer's Injection (Drug)
0.9% Sodium Chloride Injection
- administration route and dosage：Intravenous infusion, 500~1000 ml/time. The dosage can be increased or decreased according to the age, weight and symptoms.
- rate: according to the the routine rate of fluid resuscitation of septic shock in the ICUs of Zhongda Hospital, School of Medicine, Southeast University.
干预措施: 0.9% Sodium Chloride Injection (Drug)
结局指标
主要结局
the composite of death and new receipt of renal-replacement therapy MAKE30
时间窗: up to 30 days
overall incidence of death, new renal-replacement therapy, and persistent renal dysfunction within 30 days
次要结局
未报告次要终点
研究者
Jianfeng Xie
Ph.D
Southeast University, China