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Completed

NCT Number: NCT00799916

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinica Bazterrica, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resuscitation (Voluven)

Drug

Resuscitation aimed at venous oxygen saturation higher than 70%

Resuscitation (Saline)

Drug

Resuscitation aimed at venous oxygen saturation higher than 70%

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

Sponsors and collaborators

Lead sponsor

Universidad Nacional de La Plata

Other

Collaborators

  • Clínica Bazterrica
  • National Agency for Scientific and Technological Promotion, Argentina
  • Sanatorio Otamendi y Miroli

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 1, 2008
Registry last updated
Sep 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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