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Confirmatory interleukin-1 receptor antagonist trial in severe sepsis

Critical Care Medicine · 1997 · Vol. 25(7) · pp. 1115–1124

Steven M. Opal✉(Cornell University)Charles J. Fisher(Cornell University)Jean-François Dhainaut(Cornell University)Jean‐Louis Vincent(Cornell University)Rainer Brase(Cornell University)Stephen F. Lowry(Cornell University)Jerald Sadoff(Cornell University)Gus J. Slotman(Cornell University)Howard Levy(Cornell University)R.A. Balk(Cornell University)M. P. Shelly(Cornell University)John P. Pribble(Cornell University)John F. LaBrecque(Cornell University)Janice L. Lookabaugh(Cornell University)H. C. E. Donovan(Cornell University)Howard G. Dubin(Cornell University)Robert P. Baughman(Cornell University)James E. Norman(Cornell University)Eric J. DeMaria(Cornell University)Klaus E. Matzel(Cornell University)Edward Abraham(Cornell University)Michael G. Seneff(Cornell University)

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Abstract

A 72-hr, continuous intravenous infusion of rhIL-1ra failed to demonstrate a statistically significant reduction in mortality when compared with standard therapy in this multicenter clinical trial. If rhIL-1ra treatment has any therapeutic activity in severe sepsis, the incremental benefits are small and will be difficult to demonstrate in a patient population as defined by this clinical trial.

Sepsis Diagnosis and Treatment Immune Response and Inflammation Antibiotics Pharmacokinetics and EfficacyMedicinePlaceboSeptic shockInterim analysisSepsisMulticenter trialShock (circulatory)Internal medicineRandomized controlled trialAnesthesia

MeSH terms

AdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedRecombinant ProteinsShock, SepticSialoglycoproteinsSurvival AnalysisReceptors, Interleukin-1SepsisInterleukin 1 Receptor Antagonist Protein

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Overview of the <scp>IL</scp>‐1 family in innate inflammation and acquired immunity