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
  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

Resource links provided by NLM:


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
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
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Argentina
Clinica Bazterrica
Buenos Aires, Argentina, 1425
Clínica Santa Isabel
Buenos Aires, Argentina, 1425
Sanatorio Otamendi y Miroli
Buenos Aires, Argentina, 1425
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 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
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014