Document Detail


Immunoglobulin G treatment of postcardiac surgery patients with score-identified severe systemic inflammatory response syndrome--the ESSICS study.
MedLine Citation:
PMID:  18091548     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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. DESIGN: Randomized, double-blind, placebo-controlled, multicenter trial. SETTING: Intensive care units of 11 cardiothoracic centers. PATIENTS AND INTERVENTIONS: 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). INTERVENTIONS: 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). MEASUREMENTS AND MAIN 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:
Karl Werdan; Günter Pilz; Ursula Müller-Werdan; Monika Maas Enriquez; Dierk V Schmitt; Friedrich-Wilhelm Mohr; Gertraud Neeser; Friedrich Schöndube; Hans-Joachim Schäfers; Axel Haverich; Peter Fraunberger; Jan Andersson; Eckart Kreuzer; Lambert G Thijs;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Critical care medicine     Volume:  36     ISSN:  1530-0293     ISO Abbreviation:  Crit. Care Med.     Publication Date:  2008 Mar 
Date Detail:
Created Date:  2008-05-01     Completed Date:  2008-05-29     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0355501     Medline TA:  Crit Care Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  716-23     Citation Subset:  AIM; IM    
Affiliation:
Department of Medicine III, Martin-Luther-University Halle-Wittenberg, Germany. karl.werdan@medizin.uni-halle.de
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MeSH Terms
Descriptor/Qualifier:
APACHE
Aged
Cardiac Surgical Procedures / adverse effects*
Cardiopulmonary Bypass / adverse effects*
Double-Blind Method
Female
Humans
Immunoglobulin G / therapeutic use*
Male
Severity of Illness Index
Systemic Inflammatory Response Syndrome / drug therapy*,  etiology*
Chemical
Reg. No./Substance:
0/Immunoglobulin G
Investigator
Investigator/Affiliation:
K Werdan / ; G Pilz / ; U Müller-Werdan / ; E Kreuzer / ; L Thijs / ; J Andersson / ; M Maas Enriquez / ; I Muschel / ; H Beckmann / ; P Fraunberger / ; A K Walli / ; D Seidel / ; C Kuhn / ; H Schmidt / ; H-R Zerkowski / ; R-E Silber / ; B Nagy / ; D Schmitt / ; F-W Mohr / ; H Bernau / ; A Dagge / ; J Garbade / ; M Mohr / ; D Zenker / ; H Dalichau / ; S Reeh / ; Preuner / ; F Brünger / ; R Goebels / ; J Schmitt / ; D E Birnbaum / ; T Graeter / ; L Dübener / ; L Ben Mime / ; H-J Schäfers / ; M Strüber / ; Teebken / ; G Warnecke / ; I Kutschka / ; A Haverich / ; M Südkamp / ; P Pohl / ; R de Vivie / ; F Schöndube / ; P Dörge / ; R Seipelt / ; B J Messmer / ; Georgi / ; T Jost / ; Brodführer / ; S Schüler / ; G Neeser / ; L Lampart / ; C Aulmann / ; H Forst / ; M Dammann / ; M Klein /
Comments/Corrections
Comment In:
Crit Care Med. 2008 Mar;36(3):992   [PMID:  18431294 ]

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