Status:
COMPLETED
Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation
Lead Sponsor:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Severe Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if there is equivalence between two different methods of treating patients with severe bloodstream infection called sepsis. We will randomly assign patients t...
Eligibility Criteria
Inclusion
- Suspected infection
- Any two of four criteria of systemic inflammatory response
- SBP \< 90 mm Hg after 20cc/kg crystalloid (septic shock) or either a whole blood lactate \> 4 mmol/L (severe sepsis).
Exclusion
- Age \< 18 years
- Pregnancy
- Established "Do Not Resuscitate" orders prior to enrollment
- Primary diagnosis other than sepsis
- Requirement for immediate surgery in \< 6 hours from admission
- Any absolute contraindication to central venous catheterization
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00372502
Start Date
January 1 2007
End Date
December 1 2008
Last Update
January 14 2009
Active Locations (3)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
2
Cooper Hospital
Camden, New Jersey, United States
3
Carolinas Medical Center
Charlotte, North Carolina, United States