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临床试验/NCT01319630
NCT01319630已完成不适用

The Effect of Three Different Fluids(Albumin 5%, Normal Saline, HES 130 kD) on Microcirculation in Severe Sepsis/Septic Shock Patients Using Sidestream Dark Field (SDF) Microscopy and Near-Infrared Spectroscopy (NIRS) Analysis

Mercy Research1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年4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
45
试验地点
1
主要终点
Microcirculatory perfusion and flow variables

研究概览

简要总结

Major microvascular blood flow alterations have been documented in patients with severe sepsis. It was also demonstrated that the microcirculation improved in survivors of septic shock but failed to do so in patients dying from acute circulatory failure or with multiple organ failure after shock resolution. Early, effective fluid resuscitation is a key component in the management of patients with severe sepsis and septic shock with the goal of improving tissue perfusion. The best fluid in this early resuscitation phase has been and still is under debate. The aim of this study is to evaluate the effect of Three different Fluids(Albumin 5%, Normal Saline, HES 130 kD) on microcirculation in severe sepsis/septic shock patients using Sidestream Dark Field (SDF) Microscopy and Near-Infrared Spectroscopy (NIRS) analysis.

研究设计

研究类型
Observational
观察模型
Case Control
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 will be enrolled within 24 hrs of onset of severe sepsis/septic shock with an indication for fluid bolus administration.

排除标准

  • Liver cirrhosis
  • shock from other causes
  • Oral injuries (precluding SDF imaging)
  • Severe peripheral vascular disease, dialysis fistula, or mastectomies precluding safe forearm occlusion
  • Age < 18 years

结局指标

主要结局

Microcirculatory perfusion and flow variables

时间窗: 1 hour after fluid bolus

obtained by Sidestream Dark Field (SDF) microscopy

change in microcirculatory and oxygenation variables

时间窗: 1 hour after fluid bolus compared to baseline microcirculatory and oxygenation variables

obtained by both SDF and NIRS

Muscle tissue oxygenation and oxygen consumption

时间窗: 1 hour after fluid bolus

using Near Infrared spectroscopy (NIRS)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Farid Sadaka, MD

Principal Investigator

Mercy Research

研究点 (1)

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