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

Phase 2

Completed

• Conditions: Sepsis
• Interventions: Biological: GM-CSF (verum)

• Registration Number: NCT00252915
• Lead Sponsor: Charite University, Berlin, Germany

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 be achieved in patients with severe sepsis and septic shock.

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 sepsis and septic shock.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-14
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-15
• Primary Completion: 2007-01
• Study Completion: 2007-04
• Status Verified: 2009-07
• Last Update Submitted: 2011-05-24
• Last Update Posted: 2011-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum	GM-CSF (verum)	GM-CSF therapy

Primary Outcome Measures

Name	Time	Method
reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9	after therapy