Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock

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

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.

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 sepsis and septic shock.

Inclusion Criteria:

• Severe sepsis or septic shock,
• Presence of infection,
• 2 SIRS criteria,
• Acute organ dysfunction,
• Immunoparalysis,
• Informed consent

Exclusion Criteria:

• 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