NCT00252616已完成2 期
Phase III Study of Early vs. Delayed Goal Enteral Nutrition in Mechanically Ventilated Patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Ventilator-free days
研究概览
简要总结
This study tests the hypothesis that initial trophic enteral feedings will increase the time alive and free of mechanical ventilation as compared to initial goal enteral feedings in patients who are mechanically ventilated.
详细描述
Mechanically ventilated patients, within 48 hours of initiating mechanical ventilation, are randomized in a 1:1 fashion to receive trophic enteral feedings for 96 hours followed by advancement to goal feeding rates or initial advancement to goal feeding rates. Primary endpoints are ventilator free days, ICU-free days, gastrointestinal intolerances, development of nosocomial infections, and mortality.
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
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible for inclusion in the study if they meet the following criteria:
- •Mechanical ventilation expected to last at least 72 hours.
- •Presence of, or primary physician's intent to place, an enteral feeding tube and begin enteral feeds.
排除标准
- •More than 48 hours elapsed since both inclusion criteria met.
- •Patient, legal representative, or physician refuses consent or is unavailable to provide consent.
- •Patient, legal representative, or physician not committed to full support (Exception: A patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest).
- •Presence of malignant or irreversible condition and estimated 28 day mortality greater than 50%.
- •Severe or refractory shock.
- •Moribund patients not expected to survive 24 hours from start of enteral feeding (as determined by primary medical team).
- •Child-Pugh score greater than
- •Presence of partial or complete mechanical bowel obstruction, or ischemia, or infarction.
- •Current TPN use or intent to use TPN within 7 days.
- •Severe malnutrition with BMI less than 18.5 and/or loss of more than 30% total body weight in the previous 6 months.
- •Neuromuscular disease impairing the ability to ventilate spontaneously.
- •Laparotomy expected within 7 days.
- •Unable to raise head of bed 45°.
- •greater than 30% total body surface area burns.
- •Absence of GI tract/short bowel syndrome - defined as entire length of small bowel totaling 4 feet or less.
- •Presence of high-output (> 500 cc/day) enterocutaneous fistula.
- •Age less than 13 years
- •Allergy to enteral formula
结局指标
主要结局
Ventilator-free days
时间窗: day 28
次要结局
- Mortality(28 days)
- Incidence of Gastrointestinal intolerances(day 14)
- Organ failure-free days(day 28)
- ICU-free days(day 28)
- Changes in inflammation as measured by serum cytokine levels(baseline vs. days 6 and 12)
- Changes in levels of nutrition as measured by serum albumin, total protein, and pre-albumin(baseline vs. days 6 or 12)
研究者
Todd Rice
Assistant Professor
Vanderbilt University
研究点 (2)
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