title: Score-based immunoglobulin G therapy of patients with sepsis: the SBITS study.
abstract: OBJECTIVE
  Intravenous immunoglobulin as an adjunctive treatment in sepsis was regarded as promising by a Cochrane meta-analysis of smaller trials. In this phase III multicenter trial, we assessed whether intravenous immunoglobulin G (ivIgG) reduced 28-day mortality and improved morbidity in patients with score-defined severe sepsis.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled, multicenter trial.
  
  
  METHODS
  Twenty-three medical and surgical intensive care units in university centers and large teaching hospitals.
  
  
  METHODS
  Patients (n = 653) with score-defined sepsis (sepsis score 12-27) and score-defined sepsis-induced severity of disease (Acute Physiology and Chronic Health Evaluation II score 20-35).
  
  
  METHODS
  Patients were assigned to receive either placebo or ivIgG (day 0, 0.6 g/kg body weight; day 1, 0.3 g/kg body weight).
  
  
  RESULTS
  The prospectively defined primary end point was death from any cause after 28 days. Prospectively defined secondary end points were 7-day all-cause mortality, short-term change in morbidity, and pulmonary function at day 4. Six hundred fifty-three patients from 23 active centers formed the intention-to-treat group, 624 patients the per-protocol group (placebo group, n = 303; ivIgG group, n = 321). The 28-day mortality rate was 37.3% in the placebo group and 39.3% in the ivIgG group and thus not significantly different (p = .6695). Seven-day mortality was not reduced, and 4-day pulmonary function was not improved. Drug-related adverse events were rare in both groups. Exploratory findings revealed a 3-day shortening of mechanical ventilation in the surviving patients and no effect of ivIgG on plasma levels of interleukin-6 and tumor necrosis factor receptors I and II.
  
  
  CONCLUSIONS
  In patients with score-defined severe sepsis, ivIgG with a total dose of 0.9 g/kg body weight does not reduce mortality.
authors: Department of Medicine III, University Hospital, Martin-Luther-University Halle-Wittenberg, Germany. karl.werdan@medizin.uni-halle.de
authors: Karl
authors: K
authors: Werdan
authors: Günter
authors: G
authors: Pilz
authors: Oskar
authors: O
authors: Bujdoso
authors: Peter
authors: P
authors: Fraunberger
authors: Gertraud
authors: G
authors: Neeser
authors: Roland Erich
authors: RE
authors: Schmieder
authors: Burkhard
authors: B
authors: Viell
authors: Walter
authors: W
authors: Marget
authors: Margret
authors: M
authors: Seewald
authors: Peter
authors: P
authors: Walger
authors: Ralph
authors: R
authors: Stuttmann
authors: Norbert
authors: N
authors: Speichermann
authors: Claus
authors: C
authors: Peckelsen
authors: Volkhard
authors: V
authors: Kurowski
authors: Hans-Heinrich
authors: HH
authors: Osterhues
authors: Ljiljana
authors: L
authors: Verner
authors: Roswita
authors: R
authors: Neumann
authors: Ursula
authors: U
authors: Müller-Werdan
mesh_terms: D018806:APACHE; D016207:Cytokines / Q000097:blood / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000627:therapeutic use*; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018805:Sepsis / Q000276:immunology / Q000628:therapy*; D012772:Shock, Septic / Q000276:immunology / Q000628:therapy; D016019:Survival Analysis
chemical_list: D016207:Cytokines; D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors