Status:
COMPLETED
Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis
Lead Sponsor:
Universidad Nacional de La Plata
Collaborating Sponsors:
Clínica Bazterrica
Sanatorio Otamendi y Miroli
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 an...
Eligibility Criteria
Inclusion
- Severe sepsis
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00799916
Start Date
January 1 2006
End Date
August 1 2009
Last Update
September 15 2009
Active Locations (3)
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1
Clinica Bazterrica
Buenos Aires, Argentina, 1425
2
Clínica Santa Isabel
Buenos Aires, Argentina, 1425
3
Sanatorio Otamendi y Miroli
Buenos Aires, Argentina, 1425