NCT01464853终止3 期
Effect of Enteral Nutrition Support for Critically Ill Patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 84
- 试验地点
- 18
- 主要终点
- Oxygenation status improvement
研究概览
简要总结
To determine whether specialized enteral nutrition support can improve oxygenation status in critically ill patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) comparing to a standard enteral nutritional formula.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female.
- •ALI or ARDS
- •PaO2/FiO2 > 100 and ≤ 300 torr.
- •Evidence of bilateral pulmonary infiltrates/opacity on chest radiograph.
- •Enteral access
- •Systemic inflammatory response syndrome (SIRS) - two or more of the following must be present:
- •Body temperature less than 36°C or greater than 38°C
- •Heart rate > 90 beats per minute
- •Tachypnea with > 20 breaths per minute; or an arterial partial pressure of carbon dioxide < 4.3 kPa (32 mmHg)
- •White blood cell count < 4000 cells/mm³ or > 12,000 cells/mm³; or the presence of > 10% immature neutrophils.
排除标准
- •Dialysis for renal failure
- •Unable to initiate Enteral feeding within 48 hours since all inclusion criteria met.
- •Anticipated life expectancy less than 24 hours.
- •Patient with severe chronic liver disease
- •Neuromuscular disease that impairs ability to ventilate without assistance
- •Head trauma and/or drowning with a Glasgow coma score of 5
- •Receiving intravenous lipid emulsions from parenteral nutrition within 12 hours of baseline.
- •Receiving propofol
- •Airway reconstructive surgery.
- •Malignancy or irreversible disease for which 6-month mortality is greater than 50%.
- •Burns greater than 25% total body surface area.
- •Unwillingness or inability to utilize the ARDS network ventilation protocol.
- •HIV positive.
- •Chronic mechanical ventilation.
- •Severe, acute pancreatitis.
- •Refractory shock
- •Congestive heart failure with pulmonary edema as the primary cause of hypoxemia.
- •Acute myocardial infarction or cardiac surgery within 7 days.
- •Solid organ transplant.
- •INR > 5.0 or platelet count < 30,000/mm3 or history of bleeding disorder.
- •Intracranial hemorrhage within the past 30 days.
结局指标
主要结局
Oxygenation status improvement
时间窗: 28 days
次要结局
- Vitamin D status(28 days)
- Length of ventilation(28 days)
- Length of ICU stay(28 days)
- Incidence of organ failures(28 days)
- Incidence of ventilator-associated pneumonia(28 days)
- Mortality(28 days)
- Glycemic control(28 days)
- Inflammation(28 days)
研究者
研究点 (18)
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