The Effect Of Methylnaltrexone (Relistor™) on Gut Motility and Tolerance to Tube Feeding in Patients Treated With Opiate Therapy
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Hydrogen breath test measure of bowel transit
研究概览
简要总结
It is hypothesized that using methylnaltrexone in addition to pain killer narcotics (opiates) in patients will result in increased tube feeding rates with more frequent nutrition at goal calorie rate.
详细描述
Tube feeding rates and tube feeding residual volumes will be measured and followed blinded to the treatment arm (methylnaltrexone vs. placebo) to evaluate if patients (who prior to study entry did not tolerate goal rates tube feeds) can get closer to tube feeding goal with the treatment arm.
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
- 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
- •Inadequate tube feeding rate of greater than equal to 40% below goal rate.
- •Prescribed opiate therapy for pain or sedation, stable dose for minimum 48 hours
- •Stable dose or no dose laxative for minimum 72 hours
排除标准
- •Unstable Hemodynamics (eg. vasopressor medication)
- •Pregnancy
- •End stage Renal Disease on Dialysis
- •Plan to wean opiates in next 48 hours
- •Known or suspected mechanical gastrointestinal obstruction
- •Initial expired hydrogen breath level greater than 20
研究组 & 干预措施
Methylnaltrexone
干预措施: Methylnaltrexone (Drug)
saline placebo injection
干预措施: Saline injection (Drug)
结局指标
主要结局
Hydrogen breath test measure of bowel transit
时间窗: 2 days
On day 1 Hydrogen Breath Test (HBT) measures will occur 30 minutes before test meal, immediately after test meal every 15 minutes until a rise of 5ppm is detected or until 4 hours have passed. On day 2 Hydrogen Breath test measures will occur 30 minutes before test meal, immediately after test meal and every 15 minutes until a rise of 5ppm is detected or until 4 hours have passed.
次要结局
- Gastric residual volume measurement(3 days)