Randomization in The Critical Illness Stress-induced Immune Suppression Prevention Trial

Randomization
Study Description
Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial infection and sepsis remain the leading acquired causes of morbidity and mortality in critically ill children. Subsequent use of antibiotics to treat nosocomial infection and sepsis is considered a major attributable factor in the rise of antibiotic-resistant organisms in this population of children. Presently, “prophylaxis” strategies are used to prevent stress-induced gastrointestinal bleeding; however, no “prophylaxis” strategy is used to prevent stress-induced nosocomial infection and sepsis. This study used a double-blind randomized controlled trial design to test the hypothesis that daily prophylaxis with metoclopramide, zinc, selenium, and glutamine will reduce nosocomial infection and sepsis in critically ill children. Subjects were required to be less than 18 years old at time of enrollment and within 48 hours of PICU admission