The Effect of Intravenous Lipids on Lung Function in Acute Respiratory Distress Syndrome (ARDS)
2014年4月25日 更新者:W. Graham Carlos、Methodist Research Institute, Indianapolis
The Effect of Intravenous Lipid Emulsions on Lung Function in ARDS: A Pilot Study
The purpose of this study is to evaluate the effects of nutritional supplementation with omega-9 "olive-oil" and omega-6 "soybean oil" based lipid emulsions in the Acute Respiratory Distress Syndrome (ARDS).
The investigators hypothesize that these specific lipids in combination will immunomodulate the inflammatory reaction that occurs in the lungs of ARDS subjects.
This concept is known as "Pharmaconutrition."
These lipids will be given intravenously so as to assure administration and only as a supplement to enteral nutrition which all subjects will also receive.
The omega-9 will be compared to the omega-6 formulation which is the only FDA approved formulation of use in the United States since its development in 1961 by Fresenius-Kabi, Bad Homburg, Germany.
The investigators plan to perform a bronchoscopy with lavage within 24 hours of enrollment, begin the lipid administration and continue it for 96 hours after which time the investigators will repeat bronchoscopy with lavage to assess changes.
The lipid administration will cease following the second bronchoscopy.
The fluid obtained from lavage combined with serum samples obtained at the time of bronchoscopy will be analyzed for inflammatory mediators and cell counts.
Clinical data tracing will include but not be limited to: ventilator days, nutritional status, ICU time, oxygenation and lung compliance, and 30-day mortality.
研究概览
研究类型
介入性
注册 (实际的)
14
阶段
- 阶段2
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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Indiana
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Indianapolis、Indiana、美国、46202
- Methodist 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 90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:
- diagnosed with predisposing condition causing ARDS
- are mechanically ventilated through an endotracheal tube
- have enteral feeding access
- have central venous access
- have a PaO2:FiO2 ratio of less than 200
- have bilateral pulmonary infiltrates on chest x-ray
Exclusion Criteria:
- sedation requiring the use of diprivan (after enrollment)
- a clinical diagnosis of left ventricular failure
- lung cancer
- hematologic malignancy
- severe dyslipidemia
- condition precluding bronchoscopy including inability to maintain oxygen saturations greater than 90% per pulse oximetry despite conventional mechanical ventilation
- severe immunosuppression
- use of NSAIDS within previous 24 hours
- HIV positive
- pregnancy
- hypersensitivity to egg or soybean oil
- active myocardial infarction
- acute pancreatitis if complicated by hypertriglyceridemia
- severe sepsis with 2 or more organ failures
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: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 |
---|---|
实验性的:ClinOleic 20%
96 hour continuous infusion.
|
96 hour continuous infusion.
|
有源比较器:Intralipid 20%
96 hour continuous infusion.
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96 hour continuous infusion.
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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 |
---|---|
Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations
大体时间:96 hours
|
96 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Ventilator Days
大体时间:30 days
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30 days
|
|
PaO2:FiO2 Ratio
大体时间:4 days
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PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration.
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4 days
|
30天死亡率
大体时间:30天
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30天
|
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New Infection
大体时间:30 days
|
We will use standard clinical criteria including but not limited to: fever, pyuria, new inflitrate on chest x-ray, positive blood cultures, abscess detected on imaging, leukocytosis, and positive skin or soft-tissue cultures to identify presence of new bacterial infections occurring after enrollment.
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30 days
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Organ Failures
大体时间:30 days
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30 days
|
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Biomarkers (C-reactive Protein)
大体时间:96 hours
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96 hours
|
|
住院时间
大体时间:30天
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30天
|
|
Allergic Reactions
大体时间:96 hours
|
96 hours
|
|
Hypertriglyceridemia
大体时间:96 hours
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Defined as triglyceride level >400
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96 hours
|
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。
调查人员
- 首席研究员:Chris Naum, MD、Indiana 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
2010年6月1日
初级完成 (实际的)
2012年11月1日
研究完成 (实际的)
2012年11月1日
研究注册日期
首次提交
2010年3月24日
首先提交符合 QC 标准的
2010年3月30日
首次发布 (估计)
2010年3月31日
研究记录更新
最后更新发布 (估计)
2014年5月26日
上次提交的符合 QC 标准的更新
2014年4月25日
最后验证
2014年4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.
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