NCT01477697终止1 期
Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Inflammatory markers
研究概览
简要总结
This study will evaluate the effects of omega-3 fatty acid supplementation on inflammation in trauma patients. The main hypothesis is that such supplementation will reduce the presence of biomarkers of systemic inflammation, as compared to placebo
详细描述
This prospective, randomized study will evaluate the effects of omega-3 fatty acid supplementation on inflammatory response in multi-injured trauma patients. Its primary objective is to compare the intensity of inflammation between an active omega-3 group and a placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multi-system blunt trauma patients
- •Ages 18 through 65 years, inclusive
- •Admission to ICU
- •Nasogastric or nasoenteric feeding tube in place
- •Intention of primary medical team to feed the patient enterally
排除标准
- •Expected mortality within 48 hours
- •Intracranial hemorrhage
- •Pregnant or breast feeding
- •Patient, surrogate, or physician not committed to full support
- •Refractory shock
- •Unable to obtain enteral access
- •Presence of partial or complete mechanical bowel obstruction, or ischemia, or infarction
- •Current total parenteral nutrition (TPN) use, or intent to use TPN within 7 days
- •Current gastrointestinal bleeding
- •Requirement for vasopressors
结局指标
主要结局
Inflammatory markers
时间窗: Up to 28 days
Plasma levels of pro-inflammatory cytokines IL-6 and IL-8, as well as C-reactive protein
次要结局
- Infectious complications(Up to 28 days)
- Intensive Care Unit length of stay(Up to 28 days)
研究者
Krishna Athota
Assistant Clinical Professor
University of Cincinnati
研究点 (2)
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