Status:
COMPLETED
Preemptive Resuscitation for Eradication of Septic Shock
Lead Sponsor:
Christiana Care Health Services
Conditions:
Sepsis
Severe Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the ability of an empiric resuscitation strategy compared to standard care to decrease the incidence of organ failure in normotensive sepsis patients.
Detailed Description
Sepsis is a challenging and elusive entity with a high mortality rate. As a syndrome, clinicians are challenged to distinguish individuals with systemic infection warranting further interventions from...
Eligibility Criteria
Inclusion
- Emergency department patient with suspected or confirmed infection as primary reason for admission
- Serum venous lactate 2.0 - 3.9 mmol/L
- Hospital admission planned
Exclusion
- Age \< 18 years
- Pregnancy
- Serum lactate ≥ 4.0 mmol/L
- Any vasopressor or inotrope requirement
- Mechanical ventilation or non-invasive positive pressure ventilation
- Chronic end-stage renal disease requiring hemodialysis
- Pulmonary edema as diagnosed by the primary care team
- Requirement for surgery within the treatment protocol timeframe
- Inability to obtain informed consent from subject or surrogate
- Patient to receive comfort measures only
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT01449721
Start Date
September 1 2011
End Date
January 1 2016
Last Update
October 4 2017
Active Locations (5)
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1
Christiana Care Health System
Newark, Delaware, United States, 19718
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Detroit Receiving Hospital/University Health Center
Detroit, Michigan, United States, 48201
4
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216