Effects of Enteral Nutrition on Stress Ulcer Hemorrage. Multicenter Randomized Controlled
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- GI bleeding
研究概览
简要总结
Enteral nutrition can provides prophylaxis against stress ulcer bleeding in critically ill patients and there may be no need to use acid suppressing drugs for stress ulcer bleeding prophylaxis in these patients. Half of the patients on enteral nutrition will not receive any acid suppressing drugs while other half receives it. They will be followed for gastrointestinal bleeding.
详细描述
Mucosal erosions can occur on luminal surface of stomach in approximately 75-100% patients during the first 24 hours of intensive care unit admission. These erosions often cause bleeding with penetrating superficial capillaries. Clinically significant bleeding (Significant decrease in blood pressure or decrease in hemoglobin level of more than 2 g / dL) appears to be less than 5% in ICU patients.
Enteral nutrition (EN) has protective effects against stress ulcer bleeding by neutralizing the acidic pH in the stomach lumen, providing a structural and functional integrity of the mucosal surface and trophic effect on the GI mucosa. These effects have been shown in some studies. The above-mentioned studies are inadequate for clinicians to make suggestions for relation between enteral nutrition and stress ulcer hemorrhage.
The risk factors for stress ulcer hemorrhage are mechanical ventilation, coagulopathy and burns.
Proton pump inhibitors (PPI) and histamine receptor blockers (H2RB) are the main drugs used for stress ulcer bleeding prophylaxis.
Studies have shown that 90% of patients admitted to intensive care units receive prophylaxis for stress ulcer bleeding.
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
- None
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 ICU
- •Expected to stay in ICU >24 hours
- •No contraindications to EN within the first 24 hours after admission to the intensive care unit
排除标准
- •Evidence of active GI bleeding during current hospitalization prior to study entry
- •Coagulopathy (PLT<50.000, INR>1.5, aPTT>2xcontrol)
- •Patients receiving acid suppressing drugs prior to admission
- •Pregnancy or lactation
- •History/documented gastric ulcer
- •Burn>30% body surface area
- •Head injury or increased intracranial pressure
- •Partial or complete gastrectomy
- •Multi-system trauma
- •Exposure to gastric irritant drugs
- •Patients not giving informed consent
研究组 & 干预措施
Enteral nutrion only
干预措施: enteral nutrition only (Other)
Enteral nutrion + proton pump inhibitor
干预措施: enteral nutrition + proton pump inhibitor (Drug)
结局指标
主要结局
GI bleeding
时间窗: Subjects will be followed from date of randomization until discharge from the ICU or cessation of enteral nutrition up to four weeks
Overt GI bleeding (presence of coffee ground emesis hematemesis, melena or hematochezia. Significant GI bleeding, defined by 3-point decrease in hematocrit within 24 hours accompanied by overt GI bleeding or by an unexplained 6-point decrease in hematocrit during any 48 hour period.
次要结局
未报告次要终点
研究者
Kursat Gundogan
Associate Professor of Medicine and Surgery
TC Erciyes University