Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of infections
研究概览
简要总结
Recent reports suggest that most beneficial results of glutamine have been obtained with the parenteral administration of high doses of glutamine (0.35 g/Kg/d) and in some special group of patients, such as traumatic patients. Nevertheless total parenteral nutrition is not often used in critically ill patients.
The endovenous administration of the the dipeptide N(2)-L-alanyl-L-glutamine in trauma ICU patients can reduce the number of infections, ICU length of stay and mortality.
This benefit can be achieved independently the type of nutrition (enteral or parenteral nutrition), being a pharmaconutrient.
详细描述
Objective
To evaluate the efficacy of the endovenous administration endovenous glutamine to reduce the number of infectious complications, mortality and ICU length of stay in trauma ICU patients. To achieve this objective we have designed this pilot study to obtain the necessary data to design a bigger trial in the future.
Other objectives include:
- To evaluate the efficacy of glutamine in different patients regarding their severity: patients with an Injury Severity Score> 25 and patients with lower plasma levels of glutamine.
- To registry the possible adverse events of the endovenous administration of glutamine.
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
- 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
- •Moderate to severe trauma, as defined by an Injury Severity Score (ISS) > 10 points were included in the study.
- •Traumatic patients who required enteral or parenteral nutrition during the first 48 hours after hospital admission
- •Written informed consent
排除标准
- •patients whose life expectancy was less than 5 days,
- •who were allergic to glutamine,
- •Patients included in any other trial
- •Cirrhotic patients (Child C)
- •Chronic renal failure
研究组 & 干预措施
Physiological Serum
干预措施: Physiological serum (Drug)
Glutamine
干预措施: Glutamine (Drug)
结局指标
主要结局
Number of infections
时间窗: ICU discharge (median ten days)
Based on the results of the ENVIN trial, the median ICU length of stay of trauma patients admitted to the ICU in Spain, is 10 days.
次要结局
- SAfety of endovenous administration(5 days from the beginning of treatment)
- ICU Mortality(ICU mortality measured at 1 month after hospital admission)