跳至主要内容
临床试验/NCT01539551
NCT01539551Unknown不适用

Investigation of the Role of Brain Natriuretic Peptide and Lactate in Early Goal-directed Therapy for Patients With Severe Sepsis and Septic Shock

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Mortality

研究概览

简要总结

B-type natriuretic peptide (BNP) is a cardiac neurohormone which rapidly released by the ventricle in response to myocardial stretch. BNP has been used as a biomarker of sepsis related cardiac dysfunction and volume overload in critical ill patients. It is also a marker associated with prognosis in patients with severe sepsis and septic shock. However, the clinical utility of BNP level in management of early severe sepsis and septic shock over the first 48 hours is not clear. Besides, Lactate represents as a maker of tissue hypoperfusion, which has been used as a guide therapy for sepsis patients and high serum lactate level is independently associated with mortality in severe sepsis. Today, in management of early severe sepsis and septic shock, current guideline emphasize the early goal-directed therapy (EGDT) with achieving the central venous pressure (CVP) level 8-12 mmHg by fluid support first, then targeting the next goal to maintain mean airway pressure (MAP) at least 65 mmHg by vasopressor agent (ie, Norepinephrine) and finally keeping central venous oxyhemoglobin saturation (ScvO2) > 70% via optimal Hct > 30% and dobutamine usage within first 6 hours of emergency department admission. However, the role of BNP and lactate in patients with severe sepsis and septic shock with or without myocardial dysfunction under EGDT management are not clear.

The investigators will conduct a prospective observational study to investigate the change of BNP and Lactate within 48 hours in early severe sepsis and septic shock under EGDT management, their association of cardiac dysfunction and their role in predicting various clinical outcome. The investigators also want to see if BNP and lactate could be useful tools to guide the adjustment of optimal fluid supply and the timing of inotropic agent intervention.

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

  • Patients > 18 years old
  • Severe sepsis with or without septic shock

排除标准

  • Previous known heart failure or cardiomyopathy history
  • Acute coronary syndrome
  • Clinical pulmonary hypertension with various cause (iPAH, congenital heart disease, CTEPH, COPD with cor pulmonale)
  • Patients with acute pulmonary embolism
  • Chronic Af with LVH
  • Acute cerebral vascular event
  • Respiratory failure with high PEEP > 10 cmH2O)
  • Various cancer with distant metastasis
  • Patients with Bosmin therapy
  • Patients received CPR (IHCA or OHCA)
  • Massive GI bleeding or hypovolemic shock
  • Contraindication to central venous catheterization
  • Drug overdose
  • Burn injury, trauma patients
  • A requirement for immediate surgery
  • Liver cirrhosis child C

结局指标

主要结局

Mortality

时间窗: 6 months

ICU mortality, hospital mortality,

次要结局

  • Morbidity(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验