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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Nacional de La Plata
• Collaborators: Agencia de Promoción Científica y Tecnológica, Argentina, Proyecto PICT-2007-00912; Clínica Bazterrica; National Agency for Scientific and Technological Promotion, Argentina; Sanatorio Otamendi y Miroli
• Treatments: Hydroxyethyl Starch Derivatives; Pharmaceutical Solutions

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