Enteral Feeding in the Post-Injury Open Abdomen
Enteral Nutrition in the Open Abdomen
The purpose of this study is to determine if Enteral Feeding (EN) in patients with a traumatic bowel injury requiring an open abdomen impacts outcomes. Patients who receive EN will be compared to those who remain nil-per-os (NPO). Additionally, an internal study control will be performed by analyzing concurrent injured patients requiring an open abdomen who did not have a bowel injury.
Specific aims:
Hypothesis 1: EN in patients with a traumatic bowel injury requiring an open abdomen improves fascial closure rate compared to patients who remain NPO.
Hypothesis 2: EN in patients with a traumatic bowel injury requiring an open abdomen reduces infectious complications compared to patients who remain NPO.
Hypothesis 3: EN in patients with a traumatic bowel injury requiring an open abdomen have a lower mortality rate compared to patients who remain NPO.
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Colorado
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Denver、Colorado、美国、80204
- Denver Health Medical Center
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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
取样方法
研究人群
描述
Inclusion Criteria:
- All patients with a post-injury open abdomen
Exclusion Criteria:
- Patients to be excluded from analysis include deaths within 24 hours, identification of injury > 24 hours, and those transferred from an outside hospital > 24 hours following initial injury.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
bowel injury, NPO
Patients with bowel injury who remain nil-per-os (fed nothing)
|
|
bowel injury, EN
Patients with bowel injury who are fed by enteral nutrition (EN)
|
|
no bowel injury, NPO
Patients without bowl injury who remain nil-per-os (fed nothing)
|
|
no bowel injury, EN
Patient without bowl injury who are fed by enteral nutrition (EN)
|
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 |
|---|---|---|
|
fascial closure rate
大体时间：participants will be followed for their hospital stay, which is on average expected to be 1 month
|
physical exam will document fascial closure
|
participants will be followed for their hospital stay, which is on average expected to be 1 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
mortality
大体时间：participants will be followed for their hospital stay, which is on average expected to be 1 month
|
subject mortality status
|
participants will be followed for their hospital stay, which is on average expected to be 1 month
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
infectious complications
大体时间：participants will be followed for their hospital stay, which is on average expected to be 1 month
|
physical exam and imaging will be reviewed to assess infections
|
participants will be followed for their hospital stay, which is on average expected to be 1 month
|
合作者和调查者
调查人员
- 首席研究员：Clay Cothren Burlew, MD、Denver Health and Hospital Authority
研究记录日期
研究主要日期
学习开始
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 (估计)
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.