Protein Consumption in Critically Ill Patients
2018年11月2日 更新者：Société des Produits Nestlé (SPN)
Protein Consumption in Critically Ill Patients: A Retrospective Study
A retrospective study of protein intake and needs as well as outcomes in critically ill adult patients.
Data will be collected for up to 7 days of ICU stay.
研究概览
详细说明
This retrospective study of critically ill adults receiving enteral nutrition will assess the ability to meet estimated protein and energy needs via enteral nutrition.
研究类型
观察性的
注册 (实际的)
2000
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
-
-
Pennsylvania
-
Danville、Pennsylvania、美国、17822
- Geisinger Medical Center
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Scranton、Pennsylvania、美国、18510
- Geisinger Community Medical Center, Scranton, PA
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Wilkes-Barre、Pennsylvania、美国、18711
- Geisinger Wyoming Valley Medical Center
-
-
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 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
The study population will include all patients with an ICU admission receiving enteral nutrition in a 36-month period.
描述
Inclusion Criteria:
- Adult patients (age ≥18 years)
- Admitted to the ICU
- Administered at least one dose of enteral formula
Exclusion Criteria:
- Receiving exclusive oral or exclusive parenteral nutrition
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
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Daily protein intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Enteral formula utilized (Standard, High protein, Very high protein)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Daily caloric intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Estimated caloric needs (Kcal/day)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Method for estimating caloric needs (descriptive name of scale) calorie needs met.
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Percentage of daily caloric needs met (%) calorie needs met.
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Estimated protein needs (grams protein/day)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Method for estimating protein needs (descriptive name of scale)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Percentage of daily protein needs met (%)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Laboratory values (Blood Urea Nitrogen)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Laboratory values (Creatinine)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Laboratory values (Aspartate aminotransferase)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Laboratory values (Alanine transaminase)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Laboratory values (Glucose)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Laboratory values (Ammonia)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Gastrointestinal side effects observed in enterally fed patients in the ICU
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Insulin use
大体时间：Daily dose up to 7 days of ICU stay
|
Daily dose up to 7 days of ICU stay
|
|
|
Health Outcomes (Renal failure, Seizures, Encephalopathy, Hyperglycemia, Hypoglycemia)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Utilization of renal replacement therapy (Yes/No)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Utilization of medications to manage hepatic encephalopathy (lactulose) (Yes/No)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Neurocognitive status (Glasgow Coma Scale)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Presence of delirium (Yes/No)
大体时间：Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
ICU Length of Stay
大体时间：Up to 90 Days
|
Up to 90 Days
|
|
|
Hospital Length of Stay
大体时间：Up to 90 Days
|
Up to 90 Days
|
|
|
Ventilator days
大体时间：Up to 90 Days
|
Up to 90 Days
|
|
|
Antibiotic therapy days
大体时间：Up to 90 Days
|
Up to 90 Days
|
|
|
30 day readmission
大体时间：Incidence up to 30 days post discharge
|
Incidence up to 30 days post discharge
|
|
|
Death during hospitalization (Yes/No)
大体时间：Through study completion, assessed an estimated 36 months
|
Through study completion, assessed an estimated 36 months
|
|
|
Destination for discharge (home, another acute care hospital, Long Term Acute Care, rehabilitation center, nursing home)
大体时间：Through study completion, assessed an estimated 36 months
|
Destination of Discharge will be assessed via chart review.
|
Through study completion, assessed an estimated 36 months
|
|
Discharge against medical advice (Yes/No)
大体时间：Through study completion, assessed an estimated 36 months
|
Through study completion, assessed an estimated 36 months
|
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。
合作者
调查人员
- 首席研究员：Joseph Layon, MD, FACP、Geisinger Clinic
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
2016年9月1日
初级完成 (实际的)
2017年12月1日
研究完成 (实际的)
2018年9月1日
研究注册日期
首次提交
2016年10月4日
首先提交符合 QC 标准的
2017年2月7日
首次发布 (估计)
2017年2月9日
研究记录更新
最后更新发布 (实际的)
2018年11月6日
上次提交的符合 QC 标准的更新
2018年11月2日
最后验证
2018年11月1日
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.