drugset / Trial / NCT00252915

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

NCT00252915 ↗

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2005-11
Primary completion
2007-01
Completion
2007-04

Outcome

Met primary endpoint

paper After GM-CSF treatment, mHLA-DR was normalized in 19/19 treated patients, whereas this occurred in 3/19 control subjects only (P < 0.001). PMID 19590022 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject GM-CSF Protein / enzyme biologic 4 ug/kg —