title: Immunoglobulin G treatment of postcardiac surgery patients with score-identified severe systemic inflammatory response syndrome--the ESSICS study.
abstract: OBJECTIVE
  A minority of patients develop severe systemic inflammatory response syndrome (SIRS) with high mortality following cardiopulmonary bypass-assisted cardiac surgery. We assessed whether intravenous immunoglobulin G (ivIgG) improves postoperative short-term (5-day) morbidity and reduces 28-day mortality in these patients.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled, multicenter trial.
  
  
  METHODS
  Intensive care units of 11 cardiothoracic centers.
  
  
  METHODS
  Of 6,984 patients screened, we identified 244 with severe SIRS (Acute Physiology and Chronic Health Evaluation II score > or = 28 on the first postoperative day).
  
  
  METHODS
  The 244 patients with severe SIRS were randomly assigned to receive an intravenous infusion of either albumin 0.1% (placebo group, 6 mL [6 mg]/kg of body weight on day 1 and 3 mL [3 mg]/kg of body weight on day 2) or immunoglobulin G 10% (ivIgG group, 6 mL [600 mg]/kg of body weight on day 1 and 3 mL [300 mg]/kg of body weight on day 2).
  
  
  RESULTS
  The prospectively defined primary end points were improvement in morbidity on day 5 and death from any cause assessed on day 28. A total of 218 patients received both doses of the study drug (placebo n = 108, ivIgG n = 110). Acute Physiology and Chronic Health Evaluation II scores in the placebo group decreased from 31.8 +/- 4.0 (day 1) to 25.8 +/- 9.3 (day 5) and in the ivIgG group from 31.8 +/- 3.4 (day 1) to 25.9 +/- 10.3 (day 5), with no significant difference between the groups (p = .56). The 28-day mortality rate was not significantly different between the groups (per protocol population, placebo group 31.5%, ivIgG group 39.1%; intent-to-treat population, placebo group 37.2%, ivIgG group: 44.7%). No effect of ivIgG on plasma levels of interleukin-6, tumor necrosis factor, and tumor necrosis factor receptor I/II was observed. Drug-related adverse events were rare in both groups.
  
  
  CONCLUSIONS
  Patients undergoing cardiac surgery (involving cardiopulmonary bypass) who develop severe SIRS derive no improvement in short-term morbidity or 28-day mortality from ivIgG.
authors: Department of Medicine III, 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: Ursula
authors: U
authors: Müller-Werdan
authors: Monika
authors: M
authors: Maas  Enriquez
authors: Dierk V
authors: DV
authors: Schmitt
authors: Friedrich-Wilhelm
authors: FW
authors: Mohr
authors: Gertraud
authors: G
authors: Neeser
authors: Friedrich
authors: F
authors: Schöndube
authors: Hans-Joachim
authors: HJ
authors: Schäfers
authors: Axel
authors: A
authors: Haverich
authors: Peter
authors: P
authors: Fraunberger
authors: Jan
authors: J
authors: Andersson
authors: Eckart
authors: E
authors: Kreuzer
authors: Lambert G
authors: LG
authors: Thijs
mesh_terms: D018806:APACHE; D000368:Aged; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D002315:Cardiopulmonary Bypass / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D008297:Male; D012720:Severity of Illness Index; D018746:Systemic Inflammatory Response Syndrome / Q000188:drug therapy* / Q000209:etiology*
chemical_list: D007074:Immunoglobulin G