NCT00372502已完成不适用
Lactate Assessment in the Treatment of Early Sepsis: The LactATES Trial
National Institute of General Medical Sciences (NIGMS)3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2007年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Mortality
研究概览
简要总结
The purpose of this study is to determine if there is equivalence between two different methods of treating patients with severe bloodstream infection called sepsis. We will randomly assign patients to one of two treatment methods. One of the treatment methods is the current standard of care and uses an infrared sensor on the end of a catheter to determine the adequacy of treatment. The second treatment method is identical to the first but instead of the infrared sensor a blood test that is performed as a part of standard care (with blood drawn from the catheter) will be used to determine the adequacy of treatment. This study will attempt to determine an easier method of guiding treatment.
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
- 否
入选标准
- •Suspected infection
- •Any two of four criteria of systemic inflammatory response
- •SBP < 90 mm Hg after 20cc/kg crystalloid (septic shock) or either a whole blood lactate > 4 mmol/L (severe sepsis).
排除标准
- •Age < 18 years
- •Established "Do Not Resuscitate" orders prior to enrollment
- •Primary diagnosis other than sepsis
- •Requirement for immediate surgery in < 6 hours from admission
- •Any absolute contraindication to central venous catheterization
结局指标
主要结局
Mortality
时间窗: In-hospital
次要结局
未报告次要终点
研究者
研究点 (3)
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