Selective digestive tract decontamination in critically ill adults with acute brain injuries: a Post-Hoc analysis of a Randomized Clinical Trial.

Abstract

Abstract Purpose: To determine whether Selective Decontamination of the Digestive Tract (SDD) reduces in-hospital mortality in mechanically ventilated critically ill adults admitted to the Intensive Care Unit (ICU) with acute brain injuries or conditions. Methods: A post-hoc analysis from a crossover, cluster-randomized clinical trial. ICUs were randomly assigned to adopt or not to adopt a SDD strategy for two alternating 12-month periods, separated by a 3-month inter-period gap. Patients in the SDD group (n=2791; 968 admitted to the ICU with an acute brain injury) received a 6-hourly application of an oral paste and administration of a gastric suspension containing colistin, tobramycin, and nystatin for the duration of mechanical ventilation, plus a 4-day course of an intravenous antibiotic with a suitable antimicrobial spectrum. Patients in the control group (n=3191; 1093 admitted to the ICU with an acute brain injury) received standard care. The primary outcome was in-hospital mortality within 90 days. There were four secondary clinical outcomes: death in ICU, ventilator-, ICU- and hospital-free days to day 90. Results Of 2061 patients with acute brain injuries (mean age, 55.8 years; 36.4% women), all completed the trial. In patients with acute brain injuries, there were 313/968 (32.3%) and 415/1093 (38.0%) in-hospital deaths in the SDD and standard care groups (unadjusted odds ratio [OR], 0.76, 95% confidence interval [CI] 0.63 to 0.92; p = 0.004). The use of SDD was associated with statistically significant improvements in the four clinical secondary outcomes compared to standard care. There was no statistical difference in the heterogeneity of treatment effect between patients with and without acute brain injuries (interaction p=0.22). Conclusions: In this post-hoc analysis of a randomized clinical trial in critically ill patients with acute brain injuries receiving mechanical ventilation, the use of SDD significantly reduced in-hospital mortality in patients compared to standard care without SDD. These findings require confirmation. Trial Registration: Clinical Trials.gov registration number: NCT02389036