Pharmacist-Driven Stress Ulcer Prophylaxis Minimization in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- compare the incidence of overt GI bleeds
研究概览
简要总结
Pharmacologic stress ulcer prophylaxis is routinely used in the intensive care unit (ICU) to prevent upper gastrointestinal (GI) bleeding in critically ill patients.
详细描述
Historically, the two independent risk factors for stress-related GI bleeds were coagulopathy and mechanical ventilation for more than 48 hours; however, several additional risk factors have been identified, such as shock, multiple organ failure, traumatic brain injury, and major burns.
Acid suppressive medications such as proton pump inhibitors or histamine-2 receptor antagonists are prescribed to reduce the rate of bleeding from stress ulceration despite a lack of benefit from placebo-controlled trials. In addition to lack of proven benefit, the incidence of clinically significant stress-related GI bleeding has decreased over time, likely due to improvements in critical care and earlier enteral feeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years ICU location status
排除标准
- •If patient has one of the following:
- •Coagulopathy (defined as: platelets < 50,000/µL, international normalized ratio(INR) > 1.5, or partial thromboplastin time > 2 times the control value)
- •Mechanical ventilation for > 48 hours and on < 50% goal tube feeds
- •Shock state on vasopressors/inotropes and on < 50% goal tube feeds (or < 50% of diet)
- •On total parenteral nutrition
- •Use of acid suppressive therapy prior to admission
- •Admission with GI bleeding
- •History of peptic ulcer disease
- •Surgery on the GI tract or cardiac surgery during the current hospital admission
- •Pregnancy
- •H. pylori infection treatment
- •Hypersecretory disorder (ex: Zollinger-Ellison)
- •Known erosive esophagitis/gastritis (not heartburn or gastroesophageal reflux disease)
- •Traumatic brain injury with Glasgow Coma Scale score ≤ 10
- •Major burn (˃30% body surface area)
- •Major trauma requiring ICU admission
- •Spinal cord injury requiring ICU admission
- •If patient has two or more of the following:
- •Administration of ˃ 100 mg daily of prednisolone (or equivalent)
- •Acute renal failure
- •Acute hepatic failure
结局指标
主要结局
compare the incidence of overt GI bleeds
时间窗: 24 hours
To compare the incidence of overt GI bleeds (defined as hematemesis, bloody nasogastric tube aspirate, or melena) between patients who were on stress ulcer prophylaxis versus patients whose acid suppression therapy was discontinued through the stress ulcer prophylaxis minimization protocol.
次要结局
- Number of doses avoided(24 hours)
- Incidences of C.Difficile infection(24 hours)
- ICU length of stay(24 hours)
- incidence of ICU delirium(24 hours)
- type of pharmacologic agent used(24 hours)
- Identify the acid suppressive therapy reorder rate(24 hours)
- Incidences of hospital acquired pneumonia (HAP)(24 hours)
- number of discharge prescriptions for acid suppressive therapy(24 hours)
- number of patients with clinically important GI bleeding(24 hours)