Early Nutrition in Acute Pancreatitis (OZT)
Very Early and Early Nutrition in Acute Pancreatitis in Children: a Randomized Study
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Warsaw、波兰、02-091
- Departement of Paediatric Gastroenterology and Nutrition.
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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:
AP diagnosis according to the generally accepted criteria ie. fulfilling two out of three criteria:
- Abdominal pain of pancreatic origin
- Radiologic findings supportive of AP on imaging
- Amylase or lipase levels elevation three times above the upper limit of normal
- Mild or moderate AP Mild AP: AP without organ failure, local or general complications Moderate AP: AP that may be accompanied by intermittent organ failure, local complications or concomitant disease worsening
- No contradictions to enteral treatment
- Informed consent from the parents or legal guardian and from the patient if older than 16 years
Exclusion Criteria:
- Severe general condition
- Severe AP
- Kidney insufficiency, cardiac insufficiency
- Diabetes type 1
- Cystic fibrosis
- Contraindications to enteral feeding
- Lack of required informed consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Very early refeeding
Very early diet intervention: refeeding within 24 hours from the hospital admission. Participants will be encouraged to start eating immediately after the time of admission. They will be able to choose the meal from the list with no amount or calories restriction.They will be asked to conduct the daily diet diary - time of feeding, quality and quantity of the foods ingested. Laboratory tests will be performed at the study entry, on the day of 3 and 5 of hospitalization and on the day of discharge. |
Participant's diet includes several low-fiber and low-fat commonly available meals and products.
Patients will choose what they want to eat with no amount or calories restriction.
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有源比较器：Early refeeding
Early diet intervention: refeeding after 24 hours from the hospital admission . During the first 24 hours after admission participants will be on fluid only (orally and/or intravenously). Later on they will be encouraged to start eating. They will be able to choose the meal from the list with no amount or calories restriction.They will be asked to conduct the daily diet diary - time of feeding, quality and quantity of the foods ingested. Laboratory tests will be performed at the study entry, on the day of 3 and 5 of hospitalization and on the day of discharge. |
Participant's diet includes several low-fiber and low-fat commonly available meals and products.
Patients will choose what they want to eat with no amount or calories restriction.
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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 |
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Length of hospitalization
大体时间：through study completion, an average of 2 years
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Number days of hospitalization
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through study completion, an average of 2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time between the onset of symptoms and the first feeding
大体时间：assessed at the day of 2
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Time between the onset of symptoms and the first feeding measured in hours
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assessed at the day of 2
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Adverse events
大体时间：daily assessment in the first three days of hospitalization
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Severity of abdominal pain daily using a 10 point visual - analog scale (VAS).
0 means lack of the pain, 10 means the most severe pain
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daily assessment in the first three days of hospitalization
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Average calories intake
大体时间：through study completion, an average of 2 years
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Average calories intake (kcal)
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through study completion, an average of 2 years
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Levels of proinflammatory cytokine levels.
大体时间：through study completion, an average of 2 years
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Proinflammatory cytokine levels (ng/ml) using ELISA tests
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through study completion, an average of 2 years
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Zonulin level
大体时间：through study completion, an average of 2 years
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Zonulin level (ng/ml) using ELISA test
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through study completion, an average of 2 years
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Early diet intervention的临床试验
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Saranas, Inc.Cardiovascular Research Foundation, New York; Proxima Clinical Research, Inc.完全的
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人
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Rush University Medical CenterUniversity of Chicago; National Institute on Aging (NIA); Advocate Hospital System招聘中