NCT01965873已完成4 期
Enteral Nutrition for Treatment of Acute Pancreatitis - a Prospective, Randomized Clinical Trial
University Hospital Rijeka0 个研究点目标入组 214 人开始时间: 2007年5月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 主要终点
- SIRS (Systemic Inflammatory Response Syndrome)
研究概览
简要总结
The purpose of this prospective randomised clinical trial is to compare beneficial and harmful effects of the use enteral nutrition versus a nil-by-mouth and intravenous fluid replacement principle of treatment in patients with moderate to severe acute pancreatitis (AP).
The hypothesis:
- enteral nutrition is no significantly better compared with the nil-by-mouth principle regarding mortality, incidence of local and systemic complications, length of hospital stay, and intensity of the inflammatory response in patients with moderate to severe AP
- enteral nutrition has the same safety as nil-by-mouth principle in patients with moderate to severe AP
详细描述
Patients with first attack of AP irrespective of etiology will be enrolled in the study, if they are eligible according to the following criteria:
Inclusion criteria:
- onset of symptoms consistent with AP within 72 hours before admission to the hospital
- an 3-fold elevation of serum amylase or serum lipase over the upper limit of normal
- APACHE II score 6 or more
- a signed informed consent
Exclusion criteria:
- patients < 18 years of age
- pregnant and breastfeeding women
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •onset of symptoms consistent with AP within 72 hours before admission to the hospital
- •an 3-fold elevation of serum amylase or serum lipase over the upper limit of normal
- •APACHE II score 6 or more
- •a signed informed consent
排除标准
- •patients < 18 years of age
- •pregnant and breastfeeding women
结局指标
主要结局
SIRS (Systemic Inflammatory Response Syndrome)
时间窗: 4 weeks
次要结局
- Length of hospital stay(4 weeks)
- Inflammatory response (CRP on the first and third day)(First and third day of admission)
- All-cause mortality(4 weeks)
- Local complications (pancreatic necrosis, fluid collections, pseudocyst, abscess)(4 weeks)
- Other infections(4 weeks)
- Organ failure (cardiovascular, respiratory, renal)(4 weeks)
- Local septic complications(4 weeks)
- Adverse events(4 weeks)
研究者
Goran Poropat
Medical doctor
University Hospital Rijeka
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