Abstract
PurposeSurgical patients are at high risk for developing infectious complications and postoperative delirium. Prolonged infections and delirium result in worse outcome. Granulocyte-macrophage colony-stimulating factor (GM-CSF) and influenza vaccination are known to increase HLA-DR on monocytes and improve immune reactivity. This study aimed to investigate whether GM-CSF or vaccination reverses monocyte deactivation. Secondary aims were whether it decreases infection and delirium days after esophageal or pancreatic resection over time.MethodsIn this prospective, randomized, placebo-controlled, double-blind, double dummy trial setting on an interdisciplinary ICU of a university hospital 61 patients with immunosuppression (monocytic HLA-DR [mHLA-DR] <10,000 monoclonal antibodies [mAb] per cell) on the first day after esophageal or pancreatic resection were treated with either GM-CSF (250 μg/m2/d), influenza vaccination (Mutagrip 0.5 ml/d) or placebo for a maximum of 3 consecutive days if mHLA-DR remained below 10,000 mAb per cell. HLA-DR on monocytes was measured daily until day 5 after surgery. Infections and delirium were followed up for 9 days after surgery. Primary outcome was HLA-DR on monocytes, and secondary outcomes were duration of infection and delirium.ResultsmHLA-DR was significantly increased compared to placebo (p < 0.001) and influenza vaccination (p < 0.001) on the second postoperative day. Compared with placebo, GM-CSF-treated patients revealed shorter duration of infection (p < 0.001); the duration of delirium was increased after vaccination (p = 0.003).ConclusionTreatment with GM-CSF in patients with postoperative immune suppression was safe and effective in restoring monocytic immune competence. Furthermore, therapy with GM-CSF reduced duration of infection in immune compromised patients. However, influenza vaccination increased duration of delirium after major surgery.Trial Registration www.controlled-trials.com ISRCTN27114642
Highlights
Postoperative infections and delirium occur in up to 50% of high-risk patients undergoing high-risk surgery requiring intensive care unit (ICU) and prolonged hospital stay [1,2,3,4,5,6]
This study aimed to investigate whether Granulocyte-Macrophage Colony-stimulating factor (GM-CSF) or vaccination reverses monocyte deactivation
In this prospective, randomized, placebo-controlled, double-blind, double dummy trial setting on an interdisciplinary ICU of a university hospital 61 patients with immunosuppression on the first day after esophageal or pancreatic resection were treated with either GM-CSF (250 μg/m2/ d), influenza vaccination (Mutagrip 0.5 ml/d) or placebo for a maximum of 3 consecutive days if mHLA-DR remained below 10,000 monoclonal antibodies (mAb) per cell
Summary
Postoperative infections and delirium occur in up to 50% of high-risk patients undergoing high-risk surgery requiring intensive care unit (ICU) and prolonged hospital stay [1,2,3,4,5,6]. Postoperative immune suppression increases the risk for infections and delirium [11,12,13]. Prolonged downregulation of mHLA-DR has been associated with worse outcomes such as infectious complications, severe sepsis and increased mortality in ICU patients [16,17,18,19]. Whether GM-CSF or vaccination restore HLA-DR after major surgery in immunosuppressed patients is not known
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