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CompletedNCT00799916Updated Sep 15, 2009

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

A Phase 3 interventional study of Resuscitation (Voluven) and Resuscitation (Saline) in Sepsis, sponsored by Universidad Nacional de La Plata. Completed at 3 sites in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-09-15.

Sponsored by Universidad Nacional de La Plata · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Sepsis

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Keywords

  • Sepsis
  • Fluid resuscitation
  • Voluven
  • Colloids
  • Saline solution
  • Crystalloids
  • Sublingual microcirculation
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In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 30 is below the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Universidad Nacional de La Plata is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Severe sepsis

Exclusion criteria

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Voluven

    Resuscitation fluid: Voluven (R)

    Drug: Resuscitation (Voluven)

  • Active comparator
    Saline

    Resuscitation fluid: Saline solution

    Drug: Resuscitation (Saline)

Interventions

  • DrugResuscitation (Voluven)

    Resuscitation aimed at venous oxygen saturation higher than 70%

  • DrugResuscitation (Saline)

    Resuscitation aimed at venous oxygen saturation higher than 70%

06

What researchers measure

Primary outcomes

  1. Sublingual microcirculation

    Time frame: 24 hour

Secondary outcomes

  1. Gases, hemoglobin and oxygen saturations

    Time frame: 24 hours

  2. Electrolytes and lactate

    Time frame: 24 hours

  3. Anion gap corrected to albumin

    Time frame: 24 hours

07

Study locations

3 sites
  • Clinica Bazterrica
    Buenos Aires, 1425, Argentina
  • Clínica Santa Isabel
    Buenos Aires, 1425, Argentina
  • Sanatorio Otamendi y Miroli
    Buenos Aires, 1425, Argentina
08

References and documents

Publications

  • 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. PubMed 20813485 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00799916
Lead sponsor
Universidad Nacional de La Plata
Collaborators
Clínica Bazterrica, Sanatorio Otamendi y Miroli, National Agency for Scientific and Technological Promotion, Argentina
First posted
Dec 1, 2008
Start date
Jan 2006
Primary completion
Aug 2009
Completion
Aug 2009
Last update
Sep 15, 2009

Study contacts

Arnaldo Dubin, MD
principal investigator · Sanatorio Otamendi y Miroli

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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