Full Text View
Tabular View
No Study Results Posted
Related Studies
Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis
This study is currently recruiting participants.
Verified by Universidad Nacional de La Plata, March 2009
First Received: November 28, 2008   Last Updated: March 23, 2009   History of Changes
Sponsors and Collaborators: Universidad Nacional de La Plata
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
  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 III

MedlinePlus related topics: Sepsis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis

Further study details as provided by Universidad Nacional de La Plata:

Primary Outcome Measures:
  • Sublingual microcirculation [ Time Frame: 24 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Voluven: Active Comparator
Resuscitation fluid: Voluven (R)
Drug: Resuscitation (Voluven)
Resuscitation aimed at venous oxygen saturation higher than 70%
Saline: Active Comparator
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
Criteria

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 asthmaticus
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799916

Locations
Argentina
Clinica Bazterrica Recruiting
Buenos Aires, Argentina, 1425
Contact: Gastón E Murias, MD     4821 1600 ext 249     gmurias@gmail.com    
Principal Investigator: Gastón E Murias, MD            
Clínica Santa Isabel Recruiting
Buenos Aires, Argentina, 1425
Contact: Gastón E Murias, MD     4633 4800 ext 561     gmurias@gmail.com    
Principal Investigator: Gastón E Murias, MD            
Sanatorio Otamendi y Miroli Recruiting
Buenos Aires, Argentina, 1425
Contact: Arnaldo Dubin, MD     4963 8888     arnaldodubin@speedy.com.ar    
Principal Investigator: Arnaldo Dubin, MD            
Sponsors and Collaborators
Universidad Nacional de La Plata
Clínica Bazterrica
Sanatorio Otamendi y Miroli
Agencia de Promoción Científica y Tecnológica, Argentina, Proyecto PICT-2007-00912
Investigators
Principal Investigator: Arnaldo Dubin, MD Sanatorio Otamendi y Miroli
  More Information

No publications provided

Responsible Party: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) ( Analía Pérez/Dirección de evaluación de medicamentos )
Study ID Numbers: GEM 001
Study First Received: November 28, 2008
Last Updated: March 23, 2009
ClinicalTrials.gov Identifier: NCT00799916     History of Changes
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

Study placed in the following topic categories:
Systemic Inflammatory Response Syndrome
Sepsis
Inflammation

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Sepsis
Pathologic Processes
Infection
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009