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

Charite University, Berlin, Germany38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sepsis

Interventions

GM-CSF (verum)BIOLOGICAL

sagramostim

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: after therapy

Data from ClinicalTrials.gov

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