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临床试验/NCT02449928
NCT02449928Unknown不适用

Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,

Peking Union Medical College Hospital0 个研究点开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
主要终点
28-day mortality

研究概览

简要总结

Using sodium lactate Ringer's injection resuscitate septic shock patients and Compared with other solution, in order to make clear whether can improve the prognosis.

详细描述

Experimental evidence repeatedly demonstrated that the shock patients can use substrates other than glucose to sustain increased activity, including lactate.Increased lactate can be the consequence of anaerobic metabolism, i.e., the formation of lactate in the presence of low oxygen. However, emerging evidence demonstrated that in patients with sepsis increased lactate seems predominantly non-hypoxic/ischemic and rather the consequence of increased glycolysis. Utilization of lactate as an alternative fuel may be an adaptive response to maximize energy function and limit substrate reduction.Uptake of exogenous lactate has indeed been demonstrated after traumatic brain injury and acute heart failure in humans.

The investigators assume that administration of supplemental lactate significantly contributes to energy metabolism in septic shock, which can have beneficial help for septic shock resuscitation.

Inclusion criteria:diagnosis in patients with septic shock and age 18 years old or more. Exclusion criteria: pregnant women and nursing mothers, severe liver failure with child class C , use linezolid anti-infection treatment, pheochromocytoma patients, CVVH therapy patients, malignant tumor patients, using epinephrine.

The investigators will use sodium lactate Ringer's injection resuscitate septic shock patients and Compared with other solution, the organ function monitoring include heart, kidney,and brain. Others study endpoints include 28-day mortality,hospitalized mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • diagnosis in patients with septic shock

排除标准

  • pregnant women and nursing mothers
  • severe liver failure with child class C
  • using Linezolid
  • pheochromocytoma
  • hematologic malignancy
  • using epinephrine
  • during CVVH treatment

研究组 & 干预措施

lactate group,

Active Comparator

干预措施: sodium lactate Ringer's injection(Baxter, ShangHai, China) (Drug)

control group

Active Comparator

干预措施: Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China) (Drug)

结局指标

主要结局

28-day mortality

时间窗: 28 days after the diagnosis of septic shock

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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