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

Charité University Medicine Berlin

Status and phase: Completed; Phase 2

Conditions: Sepsis

Treatments: Biological: GM-CSF (verum)

Study type: Interventional

Funder types: Other

Identifiers

NCT00252915

GM-CSF-1

Details and patient eligibility

About

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.

Full 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 sepsis and septic shock.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 1 patient group

Verum

Experimental group

Description:

GM-CSF therapy

Treatment:

Biological: GM-CSF (verum)