NCT01448135已完成不适用
Pilot Study Evaluating the Efficacy, Tolerance and Safety of VITAL AF (Semi Elemental, High Protein, High Omega 3 Fat Enteral Formula) Versus Osmolite 1.2 (High Protein Enteral Formula) in Multiple ICU Settings (Medical, Surgical, Cardiothoracic)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improved tolerance to enteral (tube) feeding
研究概览
简要总结
The purpose of this pilot study is to assess the efficacy, safety and tolerance profile of the enteral feeding product VITAL AF (a semi-elemental, high protein, and high omega-3 fish oil) when compared to Osmolite 1.2, a standard feeding product in critically ill and/or post surgical patients in the intensive care unit (ICU). If enough patients are recruited, inferences about impact on outcomes may also be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject requires enteral tube feeding as sole source of nourishment
- •Subject, or subject's legally acceptable representative (LAR), has provided voluntarily and informed consent form, as deemed appropriate and approved by the Columbia University Medical Center Institutional Review Board
- •Subject is ≥ 18 years of age
- •Subject is male or non-pregnant female at least six weeks postpartum and non-lactating females of childbearing potential will be required to confirm non-pregnancy status with a pregnancy test at screening
- •Subject has an initial APACHE II score less than or equal to 24
排除标准
- •Subject requires parenteral nutrition
- •Subject is acutely impacted or constipated
- •Subject has intestinal obstruction
- •Subject is too hemodynamically unstable for enteral feeding
- •Subject has an allergy or intolerance to any ingredient in the study product by documentation or verbal report by subject or subject's LAR
- •Subject is participating in a non-Abbott approved concomitant trial
- •Subject has gastrointestinal disease, including acute pancreatitis, active gastrointestinal bleeding, acute inflammatory bowel disease, or has undergone intestinal surgery within the past month
研究组 & 干预措施
Vital AF
Experimental
干预措施: VITAL AF (Other)
Osmolite 1.2
Active Comparator
干预措施: Osmolite 1.2 (Other)
结局指标
主要结局
Improved tolerance to enteral (tube) feeding
时间窗: Baseline and 21 Days
Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.
次要结局
- Improved delivery of prescribed calories(Baseline and 21 Days)
- Decreased incidence of complications(Baseline and 21 Days)
研究者
Ira Jay Goldberg
Dickinson W. Richards, Jr. Professor of Medicine
Columbia University
研究点 (1)
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