title: Treatment of gram-negative septic shock with an immunoglobulin preparation: a prospective, randomized clinical trial.
abstract: OBJECTIVE
  To evaluate the effectiveness of a polyclonal immunoglobulin (Ig) preparation containing IgG, IgM, and IgA as an adjunctive therapy for septic shock.
  
  
  METHODS
  Prospective, randomized clinical trial.
  
  
  METHODS
  A clinical immunology ward at the center for internal medicine in a university hospital.
  
  
  METHODS
  Fifty-five patients with septic shock were randomly allocated to two groups according to criteria of septic shock.
  
  
  METHODS
  One group of patients (n = 27) received a commercially available immunoglobulin preparation (containing high titers of antibodies specific for determinants to bacterial endotoxin) during the first 3 days after inclusion in the study. The other randomized group (n = 28) did not receive any immunoglobulin preparation.
  
  
  RESULTS
  During the period of less than or equal to 6 wks after the beginning of clinically apparent septic shock, death related to the septic process occurred in one (4%) of 27 patients who received immunoglobulin. By comparison, nine (32%) of 28 control group patients died during this period (p less than .01). Within the first 48 hrs after onset of the clinically apparent septic process, significantly increased activity of circulating endotoxin and simultaneously decreased specific IgG serum titers to lipid A were detected in the group of nonsurvivors.
  
  
  CONCLUSIONS
  Administration of a polyclonal immunoglobulin preparation in the early phase of septic shock was associated with significantly improved survival.
authors.affiliation: Department of Clinical Immunology, Hannover Medical School, FRG.
authors.forename: I
authors.initials: I
authors.lastname: Schedel
authors.forename: U
authors.initials: U
authors.lastname: Dreikhausen
authors.forename: B
authors.initials: B
authors.lastname: Nentwig
authors.forename: M
authors.initials: M
authors.lastname: Höckenschnieder
authors.forename: D
authors.initials: D
authors.lastname: Rauthmann
authors.forename: S
authors.initials: S
authors.lastname: Balikcioglu
authors.forename: R
authors.initials: R
authors.lastname: Coldewey
authors.forename: H
authors.initials: H
authors.lastname: Deicher
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D001424:Bacterial Infections / Q000276:immunology / Q000401:mortality / Q000628:therapy*; D004731:Endotoxins / Q000097:blood; D005260:Female; D006090:Gram-Negative Bacteria / Q000276:immunology; D006801:Humans; D007116:Immunization, Passive / Q000379:methods; D007074:Immunoglobulin G / Q000032:analysis; D007075:Immunoglobulin M / Q000032:analysis; D008070:Lipopolysaccharides / Q000276:immunology; D008297:Male; D011446:Prospective Studies; D012772:Shock, Septic / Q000276:immunology / Q000401:mortality / Q000628:therapy*
chemical_list: D000907:Antibodies, Bacterial; D004731:Endotoxins; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D008070:Lipopolysaccharides