Iranian Intensive Care Unit (ICU) Glutamine Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Infection Probability Score
研究概览
简要总结
This is a double-blinded placebo-controlled block randomized study in intensive care patients comparing enteral glutamine supplementation to placebo. The hypothesis is an improvement of clinical and paraclinical outcomes. The primary endpoint is Infection Probability Score (IPS) and Systemic Inflammatory Response Syndrome (SIRS). Anthropometric measures and serum inflammatory mediators will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60
- •No corticosteroids use
- •No history of heart, liver and kidney diseases
- •Nutrition through nasogastric or orogastric
排除标准
- •Patients who will not tolerate enteral nutrition for more than 48 hours
- •Patients who are NPO and nutritional support has not started
- •Lactating and pregnant women
- •Kidney failure during the study
- •A history of glutamin supplement use before the study
结局指标
主要结局
Infection Probability Score
时间窗: 10 days after intervention
Infection Probability Score will be measured and will be compared to the baseline after 10 days of the intervention
Systemic Inflammatory Response Syndrome
时间窗: 10 days after intervention
Systemic Inflammatory Response Syndrome will be measured and will be compared to the baseline after 10 days of the intervention
次要结局
- Prealbumin(10 days after intervention)
- CRP(10 days after intervention)
- Serum prealbumin(10 days after the intervention)
- Length of stay (LOS)
- Bed sores(10 days after intervention)
- Mechanical ventilation(10 days after intervention)