Glutamine to Intensive Care Patients - a Prospective, Double-Blind, Placebo-Controlled Multicenter Study in the Scandinavian Countries
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- A reduction in SOFA-score
研究概览
简要总结
This is a prospective double-blinded placebo-controlled block randomized study in intensive care patients comparing intravenous glutamine supplementation to placebo. The hypothesis is an improvement of clinical outcome. The primary endpoint is a reduction in the Sequential Organ Failure Assessment (SOFA) score on day 7 of treatment.
详细描述
This is a prospective double-blinded placebo-controlled block randomised study in intensive care patients comparing intravenous glutamine supplementation (0.285 g/kg body weight/24 h) to placebo. Inclusion criteria are patients treated for more than 3 days. Primary endpoint is a reduction in SOFA-score on day 7 of treatments. Secondary endpoints are: ICU-mortality, 6-months mortality, length of ICU stay, organ failure free days as well as reduction in SOFA-score on day 10 of treatment. Nutrition will be standardised so that not less than 80% of the target which is basal energy expenditure according to Harris & Benedict is given daily. Enteral nutrition is preferred, but a combination of enteral and parenteral nutrition is recommended to achieve the nutritional target. For statistical comparison non-parametric rank order statistics will be used. To detect a 0.75-point difference in the reduction of SOFA-score on day 7 of treatment, a total of 1,000 patients will be needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admission to the ICU
- •decision to give the patient full nutrition
- •APACHE II score > 10 at admission
- •age 18-85 years
排除标准
- •readmission to the ICU after a previous ICU-stay in which the patient has been included into the study
- •subjects with any condition which in the opinion of the attending physician makes the subject unsuitable for inclusion
- •no informed consent
研究组 & 干预措施
Glutamine
Intravenous glutamine supplementation (0.285 g/kg body weight/24 h)
干预措施: Glutamine (Drug)
Control
saline
干预措施: saline (placebo) (Drug)
结局指标
主要结局
A reduction in SOFA-score
时间窗: Day 7 of treatment
次要结局
- Organ failure free days(ICU stay)
- Mortality(ICU stay and 6 months)
- Length of ICU stay(ICU stay)
- Reduction in SOFA-score(Day 10 of treatment)