title: Efficacy of single-dose intravenous immunoglobulin administration for severe sepsis and septic shock.
abstract: BACKGROUND
  Although some studies conducted outside of Japan have addressed the effectiveness of intravenous immunoglobulins (IVIG) in treating infections, the dosing regimens and amounts used in Japan are very different from those reported. Here, we investigate the effectiveness of single-dose administration of IVIG in sepsis patients in Japan.
  
  
  METHODS
  We analyzed 79 patients admitted to the intensive care unit (ICU) of a tertiary care institution due to severe sepsis or septic shock. Patients were randomly divided into a group that was administered standard divided doses of IVIG (5 g/day for 3 days, designated the S group) or a group that was administered a standard single dose of IVIG (15 g/day for 1 day, H group); freeze-dried sulfonated human IVIG was used. The longitudinal assessment of procalcitonin (PCT) levels, C-reactive protein (CRP) levels, white blood cell count, blood lactate levels, IL-6 levels, Sequential Organ Failure Assessment (SOFA) score, and Systemic Inflammatory Response Syndrome (SIRS) was conducted. We also assessed mechanical ventilation duration (days), ICU stay (days), 28-day survival rate, and 90-day survival rate.
  
  
  RESULTS
  The study showed no significant differences in PCT levels, CRP levels, 28-day survival rate, and 90-day survival rate between the two groups. However, patients in the H group showed improvements in the various SIRS diagnostic criteria, IL-6 levels, and blood lactate levels in the early stages after IVIG administration. In light of the non-recommendation of IVIG therapy in the Surviving Sepsis Campaign Guidelines 2012, our findings of significant early post-administration improvements are noteworthy. IVIG's anti-inflammatory effects may account for the early reduction in IL-6 levels after treatment, and the accompanying improvements in microcirculation may improve blood lactate levels and reduce SOFA scores. However, the low dosages of IVIG in Japan may limit the anti-cytokine effects of this treatment. Further studies are needed to determine appropriate treatment regimens of single-dose IVIG.
  
  
  CONCLUSIONS
  In this study, we investigated the effectiveness of single-dose IVIG treatment in patients with severe sepsis or septic shock. Although there were no significant effects on patient prognoses, patients who were administered single-dose IVIG showed significantly improved IL-6 levels, blood lactate levels, and disease severity scores.
authors.affiliation: General Intensive Care Unit, Hirakata Hospital, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Hamano
authors.affiliation: General Intensive Care Unit, Hirakata Hospital, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan.
authors.forename: Kenichiro
authors.initials: K
authors.lastname: Nishi
authors.affiliation: Division of Anesthesiology, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655 Japan.
authors.forename: Aki
authors.initials: A
authors.lastname: Onose
authors.affiliation: General Intensive Care Unit, Hirakata Hospital, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan.
authors.forename: Akihisa
authors.initials: A
authors.lastname: Okamoto
authors.affiliation: Department of Anesthesiology, Hirakata Hospital, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Umegaki
authors.affiliation: Department of Anesthesiology, Hirakata Hospital, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan.
authors.forename: Etsuko
authors.initials: E
authors.lastname: Yamazaki
authors.affiliation: Department of Anesthesiology, Hirakata Hospital, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan.
authors.forename: Kiichi
authors.initials: K
authors.lastname: Hirota
authors.affiliation: Department of Clinical Laboratory, Hirakata Hospital, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan.
authors.forename: Hiroe
authors.initials: H
authors.lastname: Ookura
authors.affiliation: Department of Clinical Sciences and Laboratory Medicine, Hirakata Hospital, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan.
authors.forename: Hakuo
authors.initials: H
authors.lastname: Takahashi
authors.affiliation: Department of Anesthesiology, Hirakata Hospital, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan.
authors.forename: Koh
authors.initials: K
authors.lastname: Shingu
keywords: Intravenous immunoglobulins; Severe sepsis; Single-dose administration