Status:
COMPLETED
Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
German Research Foundation
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
There is basic science evidence that GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can b...
Detailed Description
GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patinets with severe se...
Eligibility Criteria
Inclusion
- Severe sepsis or septic shock,
- Presence of infection,
- 2 SIRS criteria,
- Acute organ dysfunction,
- Immunoparalysis,
- Informed consent
Exclusion
- Pregnancy,
- Known allergies to study medication or components,
- Moribound patient,
- Autoimmune disease,
- HIV-infection,
- Acute MI or pulmonary embolism,
- Cpr during last 72 hours,
- Patients who participate in a different clinical study
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00252915
Start Date
November 1 2005
End Date
April 1 2007
Last Update
May 26 2011
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