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临床试验/NCT01362829
NCT01362829已完成不适用

Outcome Predictors in Patients With Severe Sepsis and Optimized Central Venous Oxygen Saturation

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
28-day Mortality

研究概览

简要总结

The investigators perform a prospective observation study to search for the outcome predictors (ScvO2 and lactate) in patients with severe sepsis after admission to ICU.

详细描述

Early goal-directed therapy in patients with severe sepsis or septic shock was found to provide survival benefit.It was thought that early optimization of ScvO2 within 6 hours in emergency department brought survival benefit to patients of septic shock or severe sepsis.On the other hand, early lactate clearance is associated with improved outcome in patients with severe sepsis or septic shock. In patients with severe sepsis and septic shock, those with low lactate clearance had poor prognosis, despite optimization of ScvO2. It is unknown if ScvO2 could still guide hemodynamic resuscitation after admission into ICU. The investigators perform a prospective observation study to see the correlation between ScvO2 and clinical outcome (including organ failure, disease severity, and survival) and the correlation between lactate and clinical outcome. Furthermore, if ScvO2 >= 70% is still of prognostic significance in ICU, we will investigate the outcome in patients with high ScvO2 and high serum lactate levels, and to evaluate the clinical features of this patient population.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Adult patients who are admitted to medical intensive care units with severe sepsis or septic shock

排除标准

  • Patients would be excluded if they have any one of the exclusion criteria, *including pregnancy
  • presence of acute cerebral vascular attack
  • acute cardiogenic lung edema
  • status asthmatics
  • cardiac dysrhythmia as the primary diagnosis
  • massive gastrointestinal bleeding
  • epileptics
  • drug overdose
  • requirement of immediate surgery
  • hematologic malignancies
  • febrile neutropenia
  • treatment with immunosuppressive agents before admission
  • advanced malignancy and poor pre-admission performance status
  • with inevitable short-term mortality or morbidity
  • HIV infection
  • refusal of consent

结局指标

主要结局

28-day Mortality

时间窗: 28 days

Record 28-day all-cause mortality in each population (low ScvO2, high ScvO2 and low serum lactate, high ScvO2 and high serum lactate)

次要结局

  • Severity of organ failure(1 week)
  • In-Hospital Mortality(2 months)

研究者

申办方类型
Other

研究点 (2)

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