Inmediate Feeding Tolerance in Acute Pancreatitis
Inmediate Feeding Tolerance in Patients With Mild and Acute Biliary Pancreatitis vs Early Feeding
Objective: Determine tolerance of immediate oral intake (8 hours posterior to the beginning of treatment) against traditional management (early feeding at 48hr) in patients with mild acute pancreatitis of biliary origin.
Double blind, randomized clinical trial
研究概览
详细说明
The investigators included patients 15 - 85 years old, any sex. Diagnosis of mild acute pancreatitis according to the Ranson, APACHE II and BISAP.
Signed infromed consent to participate in the study. All participants had a hepatic and biliary ultrasound to determine the biliary etiology.
The investigators excluded patients with pancreatitis of nonbiliary etiology, pregnant, severe pancreatitis, cholangitis or choledocholithiasis demonstrated during the hospital stay or with other comorbidities.
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Patients older than 15 years.
- Patients with a diagnosis of mild acute pancreatitis biliary.
- Patients who agree to enter the protocol.
Exclusion Criteria:
Patients managed at another institution.
- Patients with a diagnosis of pancreatitis of non-biliary etiology.
- Patients with heart disease or lung disease.
- Patients with organic failure.
- Patients with pregnancy.
- Patients with cholangitis.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Early oral feeding
TIME OF FEEDING.
48 hours after pancreatitis general management is started ( liquid diet)
|
Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)
|
|
实验性的：Immediate oral feeding
TIME OF FEEDING: 8 hours of after pancreatitis general management is started (enteral formula)
|
Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pancreatitis reactivation after oral Feeding
大体时间：Measures at 24hours after the begining of the oral intake
|
Resurgence of characteristically epigastric tansfictive pain, irradiated to the left, upper quadrant region after beginning the oral intake, systemic inflammatory response syndrome ( C reactive protein) or Significant leucocyte elevation
|
Measures at 24hours after the begining of the oral intake
|
|
Pancreatitis reactivation after oral Feeding
大体时间：Measures at 48hours after the begining of the oral intake
|
Resurgence of characteristically epigastric tansfictive pain, irradiated to the left, upper quadrant region after beginning the oral intake, systemic inflammatory response syndrome ( C reactive protein) or Significant leucocyte elevation
|
Measures at 48hours after the begining of the oral intake
|
合作者和调查者
调查人员
- 学习椅：Juan F Hernandez、Postgraduate office at UASLP
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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