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Sponsors and Collaborators: |
Universidad Nacional de La Plata Clínica Bazterrica Sanatorio Otamendi y Miroli Agencia de Promoción Científica y Tecnológica, Argentina, Proyecto PICT-2007-00912 |
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Information provided by: | Universidad Nacional de La Plata |
ClinicalTrials.gov Identifier: | NCT00799916 |
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.
Condition | Intervention | Phase |
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Sepsis |
Drug: Resuscitation (Voluven) Drug: Resuscitation (Saline) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis |
Estimated Enrollment: | 30 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Voluven: Active Comparator
Resuscitation fluid: Voluven (R)
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Drug: Resuscitation (Voluven)
Resuscitation aimed at venous oxygen saturation higher than 70%
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Saline: Active Comparator
Resuscitation fluid: Saline solution
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Drug: Resuscitation (Saline)
Resuscitation aimed at venous oxygen saturation higher than 70%
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Argentina | |
Clinica Bazterrica | Recruiting |
Buenos Aires, Argentina, 1425 | |
Contact: Gastón E Murias, MD 4821 1600 ext 249 gmurias@gmail.com | |
Principal Investigator: Gastón E Murias, MD | |
Clínica Santa Isabel | Recruiting |
Buenos Aires, Argentina, 1425 | |
Contact: Gastón E Murias, MD 4633 4800 ext 561 gmurias@gmail.com | |
Principal Investigator: Gastón E Murias, MD | |
Sanatorio Otamendi y Miroli | Recruiting |
Buenos Aires, Argentina, 1425 | |
Contact: Arnaldo Dubin, MD 4963 8888 arnaldodubin@speedy.com.ar | |
Principal Investigator: Arnaldo Dubin, MD |
Principal Investigator: | Arnaldo Dubin, MD | Sanatorio Otamendi y Miroli |
Responsible Party: | Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) ( Analía Pérez/Dirección de evaluación de medicamentos ) |
Study ID Numbers: | GEM 001 |
Study First Received: | November 28, 2008 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00799916 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Sepsis Fluid resuscitation Voluven Colloids |
Saline solution Crystalloids Sublingual microcirculation |
Systemic Inflammatory Response Syndrome Sepsis Inflammation |
Systemic Inflammatory Response Syndrome Sepsis Pathologic Processes Infection Inflammation |