Evaluating the Effect of Alpha Lipoic Acid on Biochemical Markers, Length of Stay and Other Important Outcomes in Patients Admitted to Intensive Care Units.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- length of stay in ICU
研究概览
简要总结
Increasing Reactive oxygen and nitrogen production occurred simultaneously with decreasing serum and intracellular level of antioxidants and enzymes in critical ill patients, which result in increasing ventilator dependency and length of stay in intensive care unit and it also accelerate organ failures in patients. In this double blind clinical trial, the investigators examine effect of alfa-lipoic acid on those patients who admitted to intensive care unit that the investigators expect to stay for more than 7 days in this ward and who have tube feeding and don't have severe liver and kidney failure, AIDS and hepatitis. After randomization of included patients by block randomization the investigators will give 900mg/day alfa-lipoic acid for ten days to treatment group and identical placebo to control group by naso-gastric tube. The purposes of this study are decreasing ventilator dependency period, length of stay in ICU, mortality and decelerate of organ failures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, 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
- •age ≥ 18;
- •expected length of stay more than 7 days;
- •using enteral feeding method during admitted to ICU
排除标准
- •having the history of autoimmune disease
- •severe renal or liver failure
- •hepatitis;
- •having severe malnutrition at the admission time;
- •having TPN at the admission time in ICU;
- •extreme intolerance to enteral feeding.
研究组 & 干预措施
alpha-lipoic acid
the patients in this arm were received 900mg alpha-lipoic acid for 10 days through nasogastric(NG) tube.
干预措施: alpha-lipoic acid (Dietary Supplement)
placebo
the patients in this arm were received 900mg placebo through NG tube.
干预措施: placebo (Drug)
结局指标
主要结局
length of stay in ICU
时间窗: day 28
number of days that patient stay in intensive care unit
mortality
时间窗: day 28
percent of mortality
ventilator free days
时间窗: 10 days
show by days
次要结局
- sequential organ failure assessment score(10 days)
- insulin resistance(10 days)
- malondialdehyde(10 days)
- total antioxidant capacity(10 days)
- C reactive protein(10 days)
- interleukin-6(10 days)
- Albumin(10 days)
- preAlbumin(10 days)
- Total lymphocyte count(10 days)
- Mid arm circumference(10 days)
- total protein(10 days)
研究者
najmeh hejazi
PhD of Nutrition,Shiraz University of Medical Sciences
Shiraz University of Medical Sciences