Sepsis Clinical Trial
Official title:
Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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