Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients Intolerant to Enteral Feeding
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Gastric emptying time
研究概览
简要总结
42 patients admitted in ICU with intolerance to enteral feeding (GRV more than 250 ml) are recruited. All patients enter a primary acetaminophen absorption test study as baseline. Serum levels of acetaminophen will be measured by florescence polarization method at 15,30,45,60,90,120,180,240,480 minutes after enteral administration of 975 mg acetaminophen. Then the patients will be randomized to methylnaltrexone or erythromycin group.Another acetaminophen absorption test with the same schedule will be done after the last dose of each drug.The area under the curve for acetaminophen blood level will be used to compare the effect of two studied drugs on gastric emptying time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted in intensive care unit in a university affiliated hospital
- •Receiving continuous enteral feeding through a nasogastric tube
- •Gastric residual volume more than 250 ml checked by aspiration technique
排除标准
- •Receiving the study drugs or metoclopramide within 24 hours of inclusion
- •Known allergy to interventional drugs or acetaminophen
- •Gastrointestinal bleeding or surgery on GI system within 24 hours of inclusion
- •Crohn's disease
- •GI perforation or obstruction
- •Short bowel syndrome
- •Liver failure or 2 of the followings:
- •Transaminase enzymes more than 3 times normal
- •Prothrombin time more than 2 times normal
- •Total bilirubin more than 3 times normal
- •Patients on hemodialysis or CRRT
- •Hemodynamically unstable patients including:
- •Mean arterial pressure less than 65 mmHg
- •Infusion of inotropes and vasopressors
- •Uncorrected acute blood loss; hemoglobin concentration less than 6.5 mg%.
- •Documented or suspected pregnancy
- •Obesity; actual body weight more than 1.5 times ideal body weight
- •Myasthenia Gravis.
- •Opioid drug abuse
研究组 & 干预措施
Erythromycin
21 patients admitted in ICU with intolerance to enteral feeding defined as more than 250 ml of gastric residual volume (GRV) found by aspiration technique.
干预措施: Erythromycin (Drug)
Methylnaltrexone
21 patients admitted in ICU with intolerance to enteral feeding defined as more than 250 ml of gastric residual volume (GRV) found by aspiration technique.
干预措施: Methylnaltrexone (Drug)
结局指标
主要结局
Gastric emptying time
时间窗: within 8 hours after drug administration
to measure gastric emptying time within 8 hours after administration of either 4 doses of 250 mg intravenous erythromycin Q6h or 2 doses of methylnaltrexone 12 mg subcutaneous Q12h with acetaminophen absorption test method
次要结局
- Tolerance to enteral feeding(24 hours after intervention)