Received: 29 November 2002 Accepted: 5 May 2003 Published online: 10 October 2003 © Springer-Verlag 2003 Electronic Supplementary Material Supplementary material is available in the online version of this article at http://dx.doi.org/10.1007/s00134-003-1956-z A. Blanco ICU, Central Hospital of Asturias, Oviedo, Spain J. E. Domínguez-Muñoz Department of Gastroenterology, University Hospital, Santiago de Compostela, Spain Abstract Objective: We compared two imipenem regimens for preven- tion of septic complications in patients with severe acute necrotizing pancre- atitis (ANP). Design and setting: Pro- spective, randomized open clinical trial involving intensive care units of 14 Spanish Hospitals. Participants: 92 patients with ANP. Interventions: Imipenem/cilastatin was administered at 500 mg four times daily starting at the time of diagnosis of ANP, within the first 96 h from the onset of symp- toms. Patients were randomized to receive antibiotic prophylaxis either for 14 days (group 1) or at least for 14 days and as long as major sys- temic complications of the disease persisted (group 2). Results: Anti- biotic was maintained in group 2 for 19.7±10.9 days. The incidence of in- fected pancreatic necrosis, pancreatic abscess, and extrapancreatic infections was 11%, 17%, and 28% in group 1 and 17.4%, 13%, and 35% in group 2 (n.s.). Pancreatic or extrapancreatic in- fection by Candida albicans occurred in 7% and 22% of patients. Global mortality was 18.5% (10.9% second- ary to septic complications), without differences between groups. In pa- tients with persisting systemic compli- cations at day 14 mortality was almost always secondary to septic complica- tions and decreased from 25% (group 1) to 8.8% (group 2) by maintaining antibiotic prophylaxis. Conclusions: Compared to a 14-day imipenem pro- phylaxis, a longer antibiotic adminis- tration in patients with ANP is not associated with a reduction in the incidence of septic complications of the disease. However, prolonged imipenem administration in patients with persisting systemic complica- tions tends to reduce mortality in ANP compared to a 14-days regimen. Keywords Severe acute pancreatitis · Acute necrotizing pancreatitis · Infected pancreatic necrosis · Pancreatic abscess · Extrapancreatic infections · Imipenem Intensive Care Med (2003) 29:1974–1980 DOI 10.1007/s00134-003-1956-z ORIGINAL Enrique Maraví-Poma Joan Gener Francisco Alvarez-Lerma Pedro Olaechea Armando Blanco J. Enrique Domínguez-Muñoz Spanish Group for the Study of Septic Complications in Severe Acute Pancreatitis Early antibiotic treatment (prophylaxis) of septic complications in severe acute necrotizing pancreatitis: a prospective, randomized, multicenter study comparing two regimens with imipenem-cilastatin Introduction Infection of pancreatic necrosis occurs in 40–70% of cases with acute necrotizing pancreatitis (ANP) and is a major cause of severe complications and mortality in these patients [1, 2, 3, 4]. Antibiotic prophylaxis has been shown to be effective in preventing infection of pancreatic necrosis [5, 6, 7, 8]. More recently a meta- analysis of the reported results has demonstrated a sig- nificant reduction in the mortality rate of ANP mediated by antibiotic prophylaxis [5]. Both from a pharmacologi- cal and from a clinical point of view imipenem/cilastatin E. Maraví-Poma ( ✉ ) ICU, Servicio Navarro de Salud-Osasunbidea, Hospital Virgen del Camino, Irunlarrea 4, 31002 Pamplona, Spain e-mail: enrique.maravi.poma@cfnavarra.es Tel.: +34-848-429851 Fax: +34-848-429924 J. Gener ICU, German i Pujol Hospital, Badalona, Spain F. Alvarez-Lerma ICU, Hospital del Mar, Barcelona, Spain P. Olaechea ICU, Galdakao Hospital, Bizkaia, Spain