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临床试验/NCT00799916
NCT00799916已完成3 期

Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis

Universidad Nacional de La Plata3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
30
试验地点
3
主要终点
Sublingual microcirculation

研究概览

简要总结

Fluid resuscitation of severe sepsis may consist of natural or artificial colloids or crystalloids. There is no evidence-based support for one type of fluid over another.

The investigators hypothesis is that fluid resuscitation with Voluven® is advantageous to normal saline solution to improve sublingual microcirculation.

详细描述

Shock is the failure of circulatory system to maintain adequate cellular perfusion. Septic shock is primarily a form of distributive shock and is characterized by ineffective tissue oxygen delivery and extraction associated with inappropriate peripheral vasodilation despite preserved or increased cardiac output. In sepsis, a complex interaction between pathologic vasodilation, relative and absolute hypovolemia, myocardial dysfunction, and altered blood flow distribution occurs due to the inflammatory response to infection. Even after the restoration of intravascular volume, microcirculatory abnormalities may persist and lead to maldistribution of cardiac output.

Notwithstanding the complexity of its pathophysiology and treatment, to maintain adequate organ perfusion is a main goal in the management of severe sepsis and septic shock. For this purpose, optimization of intravascular volume and preload is the more important step. Fluid challenge is a term used to describe the initial volume expansion period in which the response of the patient to fluid administration is carefully evaluated. During this process, large amounts of fluids may be administered over a short period of time under close monitoring to evaluate the patient's response and avoid the development of pulmonary edema. Fluid challenge should be given in all patients suspected of hypovolemia. Fluid resuscitation may consist of natural or artificial colloids or crystalloids. There is no evidence-based support for one type of fluid over another. As the volume of distribution is much larger for crystalloids than for colloids, resuscitation with crystalloids requires more fluid to achieve the same end points and might result in more edema. In addition, post-hoc analysis and experimental studies suggest that colloids might be superior to crystalloids, in terms of physiologic end-points, recruitment of the microcirculation and mortality.

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

入选标准

  • Severe sepsis

排除标准

  • Age of less than 18 years
  • Pregnancy, or the presence of an acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmatics
  • Cardiac dysrhythmias (as a primary diagnosis), contraindication to central venous catheterization, active gastrointestinal hemorrhage, seizure
  • Drug overdose, burn injury, trauma, a requirement for immediate surgery, uncured cancer (during chemotherapy
  • Immunosuppression (because of organ transplantation or systemic disease), do-not-resuscitate status, advanced directives restricting implementation of the protocol
  • Delayed admission to ICU from emergency department (more than 4 hours), or fluid resuscitation previous to ICU with more than 1,500 cc

研究组 & 干预措施

Voluven

Active Comparator

Resuscitation fluid: Voluven (R)

干预措施: Resuscitation (Voluven) (Drug)

Saline

Active Comparator

Resuscitation fluid: Saline solution

干预措施: Resuscitation (Saline) (Drug)

结局指标

主要结局

Sublingual microcirculation

时间窗: 24 hour

次要结局

  • Gases, hemoglobin and oxygen saturations(24 hours)
  • Electrolytes and lactate(24 hours)
  • Anion gap corrected to albumin(24 hours)

研究者

申办方类型
Other

研究点 (3)

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