Use of granulocyte colony-stimulating factor in patients with severe sepsis or septic shock

Purpose. The efficacy and safety of granulocyte colony-stimulating factor (G-CSF) in critically ill patients with severe sepsis or septic shock were evaluated. Summary. The medical literature was reviewed to identify published trials, case reports, and case series on the use of G-CSF in critically ill patients for treatment of severe sepsis or septic shock. G-CSF has been evaluated as an adjunct to standard care for critically ill patients. Initial studies involving critically ill patients with severe sepsis or septic shock found mortality benefits with G-CSF therapy; however, these findings are limited by factors such as small sample sizes, selection bias, and lack of an appropriate control group. Prospective, randomized, multicenter, double-blind studies failed to confirm the benefits in mortality for patients receiving G-CSF for the treatment of severe sepsis and septic shock. Due to the limitations in the design of the studies that report a mortality benefit and prospective, randomized, multicenter, double-blind studies that report the lack of a mortality benefit, a recommendation to add G-CSF as an adjunctive therapy in critically ill patients with severe sepsis and septic shock cannot be made at this time. Conclusion. The available data, especially those from large, prospective, randomized, double-blind studies, do not support the use of G-CSF as an adjunct therapy to standard care for critically ill patients with severe sepsis or septic shock. Data from prospective, large, randomized, controlled, well-designed studies are needed to define the optimal G-CSF dosing regimen, the safety of this therapy, and the effects of G-CSF on patient morbidity and survival.