Status:
COMPLETED
Extracorporeal Immune Support System (EISS) for the Treatment of Septic Patients
Lead Sponsor:
University of Rostock
Conditions:
Severe Sepsis and Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to investigate the effect of an extracorporeal application of a bed-side bioreactor containing human donor granulocytes on the course and outcome of septic shock in humans...
Eligibility Criteria
Inclusion
- sepsis with at least one organ failure (severe sepsis) or septic shock
Exclusion
- Participation in another study within the last 30 days
- Earlier participation in this study
- Pregnancy
- Bleeding, clinically not controlled (needing more than 2 red blood cell-transfusions per day)
- Hemodynamic shock for more than 12 hours (systolic BP \<90mmHg) despite adequate therapy
- HIV infection
- HCV infection, active
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00818597
Start Date
December 1 2003
End Date
June 1 2008
Last Update
January 7 2009
Active Locations (1)
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1
University of Rostock, Department of Medicine, Division of Nephrology
Rostock, Germany, 18055