Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis
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Purpose
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 |
|---|---|---|
|
Sepsis |
Drug: Resuscitation (Voluven) Drug: Resuscitation (Saline) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis |
- Sublingual microcirculation [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
- Gases, hemoglobin and oxygen saturations [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Electrolytes and lactate [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Anion gap corrected to albumin [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2006 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Voluven
Resuscitation fluid: Voluven (R)
|
Drug: Resuscitation (Voluven)
Resuscitation aimed at venous oxygen saturation higher than 70%
|
|
Active Comparator: Saline
Resuscitation fluid: Saline solution
|
Drug: Resuscitation (Saline)
Resuscitation aimed at venous oxygen saturation higher than 70%
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Argentina | |
| Clinica Bazterrica | |
| Buenos Aires, Argentina, 1425 | |
| Clínica Santa Isabel | |
| Buenos Aires, Argentina, 1425 | |
| Sanatorio Otamendi y Miroli | |
| Buenos Aires, Argentina, 1425 | |
| Principal Investigator: | Arnaldo Dubin, MD | Sanatorio Otamendi y Miroli |
More Information
No publications provided by Universidad Nacional de La Plata
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Analía Pérez/Dirección de evaluación de medicamentos, Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) |
| ClinicalTrials.gov Identifier: | NCT00799916 History of Changes |
| Other Study ID Numbers: | GEM 001 |
| Study First Received: | November 28, 2008 |
| Last Updated: | September 14, 2009 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Keywords provided by Universidad Nacional de La Plata:
|
Sepsis Fluid resuscitation Voluven Colloids |
Saline solution Crystalloids Sublingual microcirculation |
Additional relevant MeSH terms:
|
Sepsis Toxemia Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
Hetastarch Plasma Substitutes Blood Substitutes Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013