Comparison of use and non-use of prophylactic antibiotics for severe acute pancreatitis. Randomized clinical trial. Preliminary report

Abstract

Presenter: Norberto Portillo Lopez MD | Universidad de la Frontera Background: Acute pancreatitis is a frequent disease in Chile, with mortality rate of 10-30%. Prophylactic antibiotics administration has been part of severe acute pancreatitis treatment for theoretical prevention of infectious complications and mortality reduction. Yet the available evidence is controversial. The aim of this article is to demonstrate that prophylactic antibiotics do not reduce complications, need for intensive care unit bed or mortality in severe acute pancreatitis. Methods: Randomized clinical trial with simple randomization using a computational table (use or non-use of prophylactic antibiotics) of patients with severe acute pancreatitis. We define severe acute pancreatitis as APACHE II ≥ 8, C-reactive protein ≥150. In prophylactic antibiotics use group, ciprofloxacin and metronidazole were administered for 7 days. This preliminary report is presented with 50% of the calculated sample. Results: N = 150, two randomized groups; Group 1 (N = 73), without prophylactic antibiotics use, and Group 2 (N = 77) with antibiotic prophylaxis use. Twenty four patients (16%) required intensive care unit bed; twelve in Group 1, and twelve in Group 2 (p = 0.53). Ten patients (6.66%) had some type of complication, one in Group 1 and nine in Group 2 (p = 0.01). The average hospital stay was 15.7 ± 9.0 days in Group 1, and 16.8 ± 17.9 days in Group 2 (p = 0.57). Mortality was four patients (2.66%), one in Group 1 and three in Group 2 (p = 0.33). Conclusion: In this preliminary report, the prophylactic antibiotics use for severe acute pancreatitis was not shown to reduce complications, need for an intensive care unit bed or mortality.