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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
Universidad Nacional de La Plata
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
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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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