REducing Deaths Due to OXidative Stress The REDOXS© Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,223
- 试验地点
- 64
- 主要终点
- 28-day Mortality
研究概览
简要总结
The purpose of this study is to determine whether providing high dose glutamine and antioxidants to critically ill patients will be associated with improved survival.
详细描述
Background:
Critically ill patients experience a degree of hyperinflammation, cellular immune dysfunction, and oxidative stress. Supplementation with key nutrients, like glutamine and antioxidants, is most likely to have a favourable effect on these physiological parameters leading to an improvement in clinical outcomes. The results of two separate meta-analyses suggested that glutamine and antioxidants may be associated with improved survival. We have recently completed a dosing study to determine the maximal tolerable dose (MTD) of glutamine dipeptides and antioxidants in critically ill patients with evidence of hypoperfusion. The purpose of this protocol is to evaluate the effect of high dose glutamine and antioxidant supplementation on mortality in a large scale randomized trial.
Study Intervention:
Patients will be randomized to receive glutamine supplementation or antioxidant supplementation (or respective placebo).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Mechanically ventilated patients > or = 18 years old
- •2 or more organ failures related to acute illness
排除标准
- •> 24 hours from admission to ICU
- •Patients who are moribund
- •Lack of commitment to aggressive care
- •Absolute contraindication to enteral nutrients
- •Severe acquired brain injury
- •Routine elective cardiac surgery
- •Primary admission of burns > 30% body surface area
- •Weight < 50 kgms or > 200 kgms
- •Pregnant or lactating patients
- •Previous randomization in this study
- •Enrollment in a related ICU interventional study
- •Child's class C liver disease
- •Metastatic cancer with life expectancy < 6 months
- •Seizure disorder requiring anticonvulsant medication
结局指标
主要结局
28-day Mortality
时间窗: Day 28
28-day mortality/status: at 28 days after randomization;
次要结局
- ICU Length of Stay(Day 28)
- Hospital Length of Stay(6 months (from ICU admission))
- ICU Acquired Infection(Day 28)
研究者
Daren K. Heyland
Director
Clinical Evaluation Research Unit at Kingston General Hospital