Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. Prospective, Double-blind, Randomized, Placebo-controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Number of Subjects With GI Bleeding
研究概览
简要总结
study is to determine if proton pump inhibitors plus enteral nutrition is superior to enteral nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of incidence of overt and significant GI bleeding related to stress gastropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Admission to the medical ICU at University of Louisville Hospital or Jewish Hospital
- •Expected need for mechanical ventilation > 48 hours
- •No contraindication to EN within the first 24 hours after admission to the ICU
排除标准
- •Evidence of active GI bleeding during current hospitalization prior to study entry
- •Admission to ICU with primary diagnosis of burn injury
- •Closed head injury or increased intracranial pressure
- •Partial or complete gastrectomy
- •Pregnancy or lactation
研究组 & 干预措施
Pantoprazole 40mg IV daily and tube feed
干预措施: Pantoprazole 40 mg IV daily and tube feed. (Drug)
Placebo and tube feed.
干预措施: Placebo and tube feed (Other)
结局指标
主要结局
Number of Subjects With GI Bleeding
时间窗: Subjects will be followed from date of randomization until discharge from the ICU or cessation of Enteral Nutrition (EN) and successful initiation of oral feeds up to 100 weeks.
1. Incidence of overt GI bleeding (as defined by the presence of coffee ground emesis, hematemesis of bright red blood, melena, or hematochezia) seen with Proton Pump Inhibitor (PPI) and EN versus EN alone in critically ill patients. 2. Incidence of significant GI bleeding, defined by a 3-point decrease in hematocrit within 24 hours accompanied by signs of overt GI bleeding, or by an unexplained 6-point decrease in hematocrit during any 48 hour period.
次要结局
- Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis.(Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks.)
研究者
Mohamed Saad
Primary Investigator
University of Louisville