NCT01128478已完成2 期
Early Enteral Tube Feeding Compared With Pancreas Rest in Patients With Acute Pancreatitis: a Randomized Controlled Trial
University of Auckland, New Zealand1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2010年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
Pain relapse during oral refeeding occurs in at least one-fifth of patients with acute pancreatitis. The study hypothesis is that early administered enteral tube feeding might reduce a risk of pain relapse and shorten the length of hospital stay in patients with acute pancreatitis.
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
- •diagnosis of acute pancreatitis
- •age 18 years or older
- •written informed consent
排除标准
- •> 96 hours after onset of symptoms
- •> 24 hours after hospital admission
- •organ failure by the time of randomization
- •infectious complications before randomization
- •received artificial nutrition before randomization
- •previously enrolled into the trial
- •chronic pancreatitis
- •post-ERCP pancreatitis
- •intraoperative diagnosis of acute pancreatitis
- •pregnancy
- •malignancy
结局指标
主要结局
Length of hospital stay
时间窗: Up to 3 months
次要结局
- Mortality(Up to 6 months)
- Hospital readmission(Up to 6 months)
- Quality of life(Up to 6 months)
- Pain relapse(Up to 3 months)
- Local and systemic complications(Up to 3 months)
- Feeding intolerance(Up to 3 months)
- Time to solid oral food tolerated(Approx. one week)
- Pain-free time(Up to 3 months)
研究者
Max Petrov
Principal Investigator
University of Auckland, New Zealand
研究点 (1)
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