NCT01934595撤回不适用
Optimal Protein Supplementation for Critically Ill Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Cumulative Organ failure free days
研究概览
简要总结
It is well accepted that during critical illness there is an increase in protein breakdown and loss of lean body mass. Previous studies have shown that during critical illness muscle breakdown increases dramatically. The aim of our study is to test the hypothesis that critically ill patients have improved outcomes with higher protein supplementation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Medical or surgical patients who are admitted or transferred to the ICU with an APACHE II score greater than or equal to 18 and who are candidates for enteral nutrition within 48 hours of admission.
排除标准
- •• Patients who cannot tolerate enteral nutrition
- •Patients who have a contraindication for enteral nutrition per American Society of Enteral and Parenteral Nutrition guidelines (GI obstruction, intractable nausea and/or vomiting, short bowel syndrome, distal GI fistula, GI bleeding that will require endoscopy, malabsorption that requires TPN, inability to access the GI tract
- •Patients with chronic stage III or IV kidney disease and/or patients receiving dialysis within six months of this hospital admission as these patients are known to require specific protein diets as an outpatient. Patients with acute kidney injury will not be excluded as there is no evidence to suggest these patients require a specific protein diet secondary to their acute kidney injury.
- •Patients with refractory hypotension unresponsive to vasoactive medications
- •Patients who are unlikely to survive the next 48 hours at the time of enrollment (this will be judged by the treating physician)
- •Patients who are unable to give consent and do not have a family member able to give consent on his/her behalf.
- •Patients with end stage liver disease or undergoing liver transplant or liver resection surgery
- •Patients whose physician thinks he/she should not participate
- •Prisoners
- •Pregnant women (all female of childbearing age will have a urine pregnancy test prior to randomization)
结局指标
主要结局
Cumulative Organ failure free days
时间窗: 28 days
The primary outcome will be cumulative organ failure free days (defined as no aggressive medical support for the patient's vital organ systems; including cardiovascular, respiratory, renal, bone marrow, and liver.
次要结局
- Mortality(28 days)
研究者
研究点 (2)
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