Influence of Granulocyte-Macrophage Colony-Stimulating Factor or Influenza Vaccination on HLA-DR, Infection and Delirium Days in Immunosuppressed Surgical Patients: Double Blind, Randomised Controlled Trial

PLoS One. 2015 Dec 7;10(12):e0144003. doi: 10.1371/journal.pone.0144003. eCollection 2015.

Abstract

Purpose: Surgical 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.

Methods: In 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.

Results: mHLA-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).

Conclusion: Treatment 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Delirium* / metabolism
  • Delirium* / physiopathology
  • Double-Blind Method
  • Esophagus / surgery
  • Female
  • Granulocyte-Macrophage Colony-Stimulating Factor / administration & dosage*
  • HLA-DR Antigens / metabolism*
  • Humans
  • Immunocompromised Host*
  • Influenza Vaccines / administration & dosage*
  • Influenza Vaccines / adverse effects
  • Influenza, Human / metabolism
  • Influenza, Human / physiopathology
  • Influenza, Human / prevention & control
  • Male
  • Middle Aged
  • Monocytes / metabolism
  • Pancreas / surgery
  • Vaccination*

Substances

  • HLA-DR Antigens
  • Influenza Vaccines
  • Granulocyte-Macrophage Colony-Stimulating Factor

Associated data

  • ISRCTN/ISRCTN27114642

Grants and funding

Funding provided by Deutsche Forschungsgemeinschaft (DFG SP432-1), http://www.dfg.de/ and Charité - Universitätsmedizin Berlin (www.charite.de). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. One of the co-authors, Professor Klaus-Dieter Wernecke, is the owner of the commercial company Sostana GmbH Berlin. However, there are no conflicts of interests in this case. The funders of our study, ‘Deutsche Forschungsgemeinschaft’ and inneruniversitary grants, provided financial support in form of salaries for authors, but did not have any additional role in the study design, data collection and analysis, decision to publish or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.