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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799916
• Other study ID #: GEM 001
• Status: Completed
• Phase: Phase 3
• First received: November 28, 2008
• Last updated: September 14, 2009
• Start date: January 2006
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: Universidad Nacional de La Plata
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Severe sepsis

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Drug:
• Resuscitation (Voluven)
Resuscitation aimed at venous oxygen saturation higher than 70%
• Resuscitation (Saline)
Resuscitation aimed at venous oxygen saturation higher than 70%

Locations

Country	Name	City	State
Argentina	Clinica Bazterrica	Buenos Aires
Argentina	Clínica Santa Isabel	Buenos Aires
Argentina	Sanatorio Otamendi y Miroli	Buenos Aires

Sponsors (4)

Lead Sponsor	Collaborator
Universidad Nacional de La Plata	Agencia de Promoción Científica y Tecnológica, Argentina, Proyecto PICT-2007-00912, Clínica Bazterrica, Sanatorio Otamendi y Miroli

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sublingual microcirculation		24 hour	No
Secondary	Gases, hemoglobin and oxygen saturations		24 hours	No
Secondary	Electrolytes and lactate		24 hours	No
Secondary	Anion gap corrected to albumin		24 hours	No