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

This study has been completed.
Sponsor:
Collaborators:
Clínica Bazterrica
Sanatorio Otamendi y Miroli
Agencia de Promoción Científica y Tecnológica, Argentina, Proyecto PICT-2007-00912
Information provided by:
Universidad Nacional de La Plata
ClinicalTrials.gov Identifier:
NCT00799916
First received: November 28, 2008
Last updated: September 14, 2009
Last verified: September 2009

November 28, 2008
September 14, 2009
January 2006
August 2009   (final data collection date for primary outcome measure)
Sublingual microcirculation [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00799916 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Sepsis
  • Drug: Resuscitation (Voluven)
    Resuscitation aimed at venous oxygen saturation higher than 70%
  • Drug: Resuscitation (Saline)
    Resuscitation aimed at venous oxygen saturation higher than 70%
  • Active Comparator: Voluven
    Resuscitation fluid: Voluven (R)
    Intervention: Drug: Resuscitation (Voluven)
  • Active Comparator: Saline
    Resuscitation fluid: Saline solution
    Intervention: Drug: Resuscitation (Saline)
Dubin A, Pozo MO, Casabella CA, Murias G, Pálizas F Jr, Moseinco MC, Kanoore Edul VS, Pálizas F, Estenssoro E, Ince C. Comparison of 6% hydroxyethyl starch 130/0.4 and saline solution for resuscitation of the microcirculation during the early goal-directed therapy of septic patients. J Crit Care. 2010 Dec;25(4):659.e1-8. Epub 2010 Sep 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT00799916
GEM 001
No
Analía Pérez/Dirección de evaluación de medicamentos, Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)
Universidad Nacional de La Plata
  • Clínica Bazterrica
  • Sanatorio Otamendi y Miroli
  • Agencia de Promoción Científica y Tecnológica, Argentina, Proyecto PICT-2007-00912
Principal Investigator: Arnaldo Dubin, MD Sanatorio Otamendi y Miroli
Universidad Nacional de La Plata
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP