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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00799916
Enrollment
30
Registered
2008-12-01
Start date
2006-01-31
Completion date
2009-08-31
Last updated
2009-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

Sepsis, Fluid resuscitation, Voluven, Colloids, Saline solution, Crystalloids, Sublingual microcirculation

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.

Interventions

Resuscitation aimed at venous oxygen saturation higher than 70%

DRUGResuscitation (Saline)

Resuscitation aimed at venous oxygen saturation higher than 70%

Sponsors

Clínica Bazterrica
CollaboratorOTHER
Sanatorio Otamendi y Miroli
CollaboratorUNKNOWN
National Agency for Scientific and Technological Promotion, Argentina
CollaboratorOTHER
Universidad Nacional de La Plata
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Sublingual microcirculation24 hour

Secondary

MeasureTime frame
Gases, hemoglobin and oxygen saturations24 hours
Electrolytes and lactate24 hours
Anion gap corrected to albumin24 hours

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026