Patient-Initiated and ConTrolled Oral Refeeding (PICTOR) (PICTOR)
2019年9月24日 更新者：Max Petrov、University of Auckland, New Zealand
A Randomized Controlled Trial of Patient-Initiated and ConTrolled Oral Refeeding in Acute Pancreatitis
The first step in treating patients with acute pancreatitis is to provide pain relief and intravenous fluids to keep them comfortable. As the pain subsides and patient starts to feel better food and fluids by mouth are restarted. This is done to rest the pancreas which is the organ that has been inflamed.
In some patients when food by mouth restarts they have pain and as a consequence they have a longer stay in hospital. It is thought that patients who have little pain and are within 24 hours of admission to hospital do well if they control their own food intake. This is in contrast to the usual treatment where the treating team advise when eating should restart.
研究概览
研究类型
介入性
注册 (实际的)
56
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
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Auckland、新西兰
- University of Auckland; Auckland City Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- diagnosis of acute pancreatitis
- age > 18 years
- written informed consent
Exclusion Criteria:
- ongoing need for opiates
- >96 hours after onset of symptoms
- chronic pancreatitis
- post-ERCP pancreatitis
- intraoperative diagnosis
- pregnancy
- malignancy
- received nutrition before randomisation
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：常规管理
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实验性的：Patient-controlled oral refeeding
Patients will be allowed to drink and eat hospital food freely as tolerated.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Oral food intolerance
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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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 from admission until tolerance of oral food
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Total length of hospital stay
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
|
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Need for opiates
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
Need for opiates is defined when one (or more) of the following has been administered:
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
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Change in pain intensity
大体时间：Baseline and 24, 48, 72h after randomisation
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Baseline and 24, 48, 72h after randomisation
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Progression of acute pancreatitis severity
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 7 days
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To be defined according to the 2012 determinant-based classification of acute pancreatitis severity
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Hospital readmission
大体时间：2 weeks after hospital discharge
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2 weeks after hospital discharge
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Local and systemic complications
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
To be defined according to the 2012 determinant-based classification of acute pancreatitis severity
|
Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
|
Number and type of interventions during hospital stay
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
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Time from admission until first flatus
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Change in blood glucose
大体时间：Baseline and 24, 48, 72h after randomisation
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Baseline and 24, 48, 72h after randomisation
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Change in plasma C-reactive protein
大体时间：Baseline and 24, 48, 72h after randomisation
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Baseline and 24, 48, 72h after randomisation
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年12月1日
初级完成 (实际的)
2018年6月1日
研究完成 (实际的)
2019年6月1日
研究注册日期
首次提交
2012年11月5日
首先提交符合 QC 标准的
2012年11月13日
首次发布 (估计)
2012年11月20日
研究记录更新
最后更新发布 (实际的)
2019年9月26日
上次提交的符合 QC 标准的更新
2019年9月24日
最后验证
2019年9月1日
更多信息
与本研究相关的术语
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.