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

PELOD
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

PELOD 研究概况
尽管严格落实手卫生、无菌操作规范并使用抗生素涂层导管，医院获得性感染（nosocomial infection）与脓毒症（sepsis）仍是重症儿童院内继发的主要致病与致死诱因。针对医院获得性感染与脓毒症的后续抗生素治疗，被视为该儿童群体中抗生素耐药菌（antibiotic-resistant organisms）滋生的主要可归因风险因素。目前，临床已采用“预防”策略干预应激性胃肠道出血（stress-induced gastrointestinal bleeding），但尚无针对应激性医院获得性感染与脓毒症的预防方案。本研究采用双盲随机对照试验（double-blind randomized controlled trial）设计，旨在验证如下假说：每日给予甲氧氯普胺、锌、硒及谷氨酰胺进行预防干预，可降低重症儿童的医院获得性感染与脓毒症发生率。研究对象需满足入组时年龄未满18周岁，且于儿科重症监护室（Pediatric Intensive Care Unit, PICU）收治后48小时内入组。