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临床试验/NCT02706379
NCT02706379Unknown不适用

The Impact of Early Goal-Directed Therapy to Perfusion and Metabolism of Brain in Septic Shock Patients

Southeast University, China0 个研究点目标入组 26 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
26
主要终点
change of local cerebral oxygen saturation between early goal directed treatment(EGDT)

研究概览

简要总结

Early goal directed therapy (EGDT) is an effective treatment for patients with septic shock, which is widely used in clinic. Fluid resuscitation can significantly reduce the mortality of patients with septic shock and improve the prognosis of patients with EGDT. However, in recent years, the standard of EGDT to determine the existence of the target of septic shock. Some studies have shown that there may be a manifestation of the deficiency of kidney and liver and other organs such as kidney, liver and other organs in the recovery of EGDT. Therefore, this experiment is to explore the brain perfusion and metabolism of the EGDT when the target is reached.The aim of this study was to investigate the effects of EGDT as a guide to the cerebral perfusion and metabolism in order to provide clinical evidence for the treatment of fluid resuscitation in patients with septic shock.

详细描述

  1. patients enrollment this project: Met the inclusion criteria without exclusion criteria were entered test, and record the general information, including name, hospital number, gender, age, height, weight, admission, and in time, ICU admission and in ICU diagnosis, previous underlying diseases, into the group of APACHE II score and SOFA score
  2. implement septic shock bundle: measurement the value of lactic acid of patients after administrating of ICU, take blood culture before antibiotic using, give wide-spectrum antibiotic treatment and began liquid resuscitation
  3. preparation: A. basic state records B. using CAM-ICU delirium assessment for patients, and record the assessment results C. cerebral oxygen saturation monitor D. via the jugular vein placed central venous catheter and femoral artery placed PiCCO catheter
  4. monitoring of hemodynamics and cerebral perfusion and metabolic indicators

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • New infectious shock in accordance with the diagnostic criteria of the 2012 SSC guidelines;
  • Liquid recovery is not fully achieved EGDT standards, at least meet the following criteria:
  • mean arterial pressure < 65mmHg
  • central venous pressure < 8mmHg
  • per hour urine volume was less than 0.5ml/kg
  • central venous oxygen saturation <70%
  • arterial blood lactic acid value > 2.5mmol/L
  • Signed informed consent

排除标准

  • Subjects/subjects client reject the invasive hemodynamic monitoring
  • have contraindications to place hemodynamic monitoring
  • unconsciousness state before septic shock and GCS<12
  • cannot put the electrodes on the eyebrow
  • pregnant or lactating women
  • end stage of illness or death rate is more than 80%

结局指标

主要结局

change of local cerebral oxygen saturation between early goal directed treatment(EGDT)

时间窗: through study completion, up to 6 hours

Test the local cerebral oxygen saturation of both sides of brain through near infrared spectroscopy technology. And record the change of local cerebral oxygen of the left and right's brain.

次要结局

  • change of S-100 protein(through study completion, up to 6 hours)
  • change of neuron specific enolase(NSE)(through study completion, up to 6 hours)

研究者

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jingyuan,Xu

director

Southeast University, China

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