Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis
Primary Purpose
Sepsis
Status
Completed
Phase
Phase 3
Locations
Argentina
Study Type
Interventional
Intervention
Resuscitation (Voluven)
Resuscitation (Saline)
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Fluid resuscitation, Voluven, Colloids, Saline solution, Crystalloids, Sublingual microcirculation
Eligibility 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
Sites / Locations
- Clinica Bazterrica
- Clínica Santa Isabel
- Sanatorio Otamendi y Miroli
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Voluven
Saline
Arm Description
Resuscitation fluid: Voluven (R)
Resuscitation fluid: Saline solution
Outcomes
Primary Outcome Measures
Sublingual microcirculation
Secondary Outcome Measures
Gases, hemoglobin and oxygen saturations
Electrolytes and lactate
Anion gap corrected to albumin
Full Information
NCT ID
NCT00799916
First Posted
November 28, 2008
Last Updated
September 14, 2009
Sponsor
Universidad Nacional de La Plata
Collaborators
Clínica Bazterrica, Sanatorio Otamendi y Miroli, National Agency for Scientific and Technological Promotion, Argentina
1. Study Identification
Unique Protocol Identification Number
NCT00799916
Brief Title
Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis
Official Title
Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidad Nacional de La Plata
Collaborators
Clínica Bazterrica, Sanatorio Otamendi y Miroli, National Agency for Scientific and Technological Promotion, Argentina
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Sepsis, Fluid resuscitation, Voluven, Colloids, Saline solution, Crystalloids, Sublingual microcirculation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Voluven
Arm Type
Active Comparator
Arm Description
Resuscitation fluid: Voluven (R)
Arm Title
Saline
Arm Type
Active Comparator
Arm Description
Resuscitation fluid: Saline solution
Intervention Type
Drug
Intervention Name(s)
Resuscitation (Voluven)
Intervention Description
Resuscitation aimed at venous oxygen saturation higher than 70%
Intervention Type
Drug
Intervention Name(s)
Resuscitation (Saline)
Intervention Description
Resuscitation aimed at venous oxygen saturation higher than 70%
Primary Outcome Measure Information:
Title
Sublingual microcirculation
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Gases, hemoglobin and oxygen saturations
Time Frame
24 hours
Title
Electrolytes and lactate
Time Frame
24 hours
Title
Anion gap corrected to albumin
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaldo Dubin, MD
Organizational Affiliation
Sanatorio Otamendi y Miroli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Bazterrica
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Clínica Santa Isabel
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Sanatorio Otamendi y Miroli
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
12. IPD Sharing Statement
Citations:
PubMed Identifier
20813485
Citation
Dubin A, Pozo MO, Casabella CA, Murias G, Palizas F Jr, Moseinco MC, Kanoore Edul VS, Palizas 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. doi: 10.1016/j.jcrc.2010.04.007. Epub 2010 Sep 1.
Results Reference
derived
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Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis
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