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

Phase 3

Completed

• Conditions: Sepsis
• Interventions: Drug: Resuscitation (Voluven); Drug: Resuscitation (Saline)

• Registration Number: NCT00799916
• Lead Sponsor: Universidad Nacional de La Plata

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-11-28
• Study First Submitted QC: 2008-11-28
• Study First Posted: 2008-12-01
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Voluven	Resuscitation (Voluven)	Resuscitation fluid: Voluven (R)
Saline	Resuscitation (Saline)	Resuscitation fluid: Saline solution

Primary Outcome Measures

Name	Time	Method
Sublingual microcirculation	24 hour

Secondary Outcome Measures

Name	Time	Method
Gases, hemoglobin and oxygen saturations	24 hours
Electrolytes and lactate	24 hours
Anion gap corrected to albumin	24 hours

Trial Locations

Locations (3)

Clinica Bazterrica; 🇦🇷 Buenos Aires, Argentina

Clínica Santa Isabel; 🇦🇷 Buenos Aires, Argentina

Sanatorio Otamendi y Miroli; 🇦🇷 Buenos Aires, Argentina