Critical Care Medicine. 36(3):716-723, MARCH 2008

DOI: 10.1097/01.CCM.0B013E3181611F62F

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PMID: 18091548

Issn Print: 0090-3493

Publication Date: March 2008


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Immunoglobulin G treatment of postcardiac surgery patients with score-identified severe systemic inflammatory response syndrome—The ESSICS study*

Karl Werdan;Günter Pilz;Ursula Müller-Werdan;Monika Enriquez;Dierk Schmitt;Friedrich-Wilhelm Mohr;Gertraud Neeser;Friedrich Schöndube;Hans-Joachim Schäfers;Axel Haverich;Peter Fraunberger;Jan Andersson;Eckart Kreuzer;Lambert Thijs;

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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.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 ≥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.

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