Effects of Enteral Glutamine on Inflammatory Response, Immune System Function and Clinical Outcomes in Hospitalized Patients With Enteral Feeding in Intensive Care Unit
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Occurrence of infection
研究概览
简要总结
Glutamine supplementation has beneficial effects on morbidity and mortality in critically ill patients, possibly in part through an attenuation of the proinflammatory cytokine response and a Immune function. In this trial intensive care unit patients with enteral feeding will receive either enteral glutamine or maltodextrin as placebo for 28 days.
详细描述
A randomized, double blind, controlled trial will be conducted in general intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 200 eligible hospitalized patients with enteral feeding in ICU, aged ≥ 18 years. Intervention patients will be received 0.3 g/kg/day of glutamine along with enteral formula for 28 days and control patients will be received maltodextrin along with enteral formula for 28 days. Patients will be evaluated for occurrence of new infection, organ failure, duration of stay in ICU, 28 days and 6 months mortality and inflammatory and immune markers.
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
- •Adult patients (>18 years old) admitted to ICU
- •Start of study intervention within 48 hours after ICU admission
- •Expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition and receive at least 80 percent of enteral formula during the first 48 hour
- •Written informed consent of patient or written informed consent of legal representative
排除标准
- •Enrollment in a related ICU interventional study
- •Requiring other specific enteral nutrition for medical reason
- •Death or Discharge before 5th day
- •Having any contra-indication to receive enteral nutrition
- •Pregnant patients or lactating with the intent to breastfeed
- •Requiring other specific enteral nutrition for medical reason
- •BMI <18 or > 40.0 kg/m2
- •Have life expectancy of <6 mo
- •Patients who are moribond
- •Liver cirrhosis- Child's class C liver disease
- •Have seizure disorder requiring anticonvulsant
- •History of allergy or intolerance to the study product components
- •Receiving glutamine during two weeks before start study product
- •Have other reasons
研究组 & 干预措施
Glutamin
Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.
干预措施: Glutamin (Drug)
maltodextrin
Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
干预措施: Maltodextrin (Other)
结局指标
主要结局
Occurrence of infection
时间窗: Day 28
Incidence of infections
次要结局
- Serum Immunity Markers(baseline, Day 5, Day 10)
- Length of stay in ICU(Day 28)
- Serum Inflammatory Markers(baseline, Day 5, Day 10)
- 28-day Mortality(Day 28)
- 6-month mortality(month 6)
研究者
Zahra Vahdat Shariatpanahi
Associate Professor
Shahid Beheshti University