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Sponsors and Collaborators: |
Charite University, Berlin, Germany German Research Foundation |
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Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00252915 |
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 be achieved in patients with severe sepsis and septic shock.
Condition | Intervention | Phase |
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Sepsis Immunoparalysis |
Drug: GM-CSF (verum) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | Reconstruction of Monocytic Immunocompetence by Granulocyte-Macrophage-Colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock: a Prospective, Randomised, Double-Blind, Placebo-Controlled Study |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Charite University Medicine | |
Berlin, Germany, 13353 |
Principal Investigator: | Hans-Dieter Volk, Prof. Dr. | Charite University Medicine Berlin |
Study ID Numbers: | GM-CSF-1 |
Study First Received: | November 14, 2005 |
Last Updated: | May 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00252915 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Systemic Inflammatory Response Syndrome Sepsis Shock Shock, Septic Inflammation |
Pathologic Processes Infection |