The Impact of Glutamine Supplementation Upon the Short-term Mortality of COVID-19 Diseased Patients Admitted in ICU: A Double Blind Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ICU mortality
研究概览
简要总结
The aim of this study is to investigate the effect of parenteral L-Glutamine supplementation added to enteral nutrition on short-term ICU mortality (7 days) in Covid-19 diseased patients.
详细描述
A written informed consent will be taken from the patients or their relatives. Patients with diagnosis of covid-19 with enteral nutrition will be enrolled. Patients will be randomly assigned to receive either standard enteral nutrition (Group EN) or intravenous glutamine supplementation to enteral nutrition (group GN) in a dose of glutamine of 0.4 g/kg/day during ICU stay.
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
- Double (Participant, Care Provider)
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
- •Diagnosis of covid-19 diseased patients admitted to the ICU with enteral nutrition.
排除标准
- •Renal failure (creatinine >180 mmol/l)
- •Hepatic failure (bilirubin >40 mmol/l, alanine aminotransferase >100 U/l and aspartate aminotransferase >100 U/l)
- •Severe neutropenia (<500 cells/mm3)
- •Patients receiving cytotoxic, radiation and/or steroid therapy
- •Hemodynamic instability
研究组 & 干预措施
Group EN (standard enteral nutrition)
Patients receive standard enteral nutrition according to ICU nutrition protocol during 7days from admission
干预措施: Standard enteral nutrition (Dietary Supplement)
Group GN (glutamine supplemented enteral nutrition)
Patients receive intravenous glutamine supplementation to enteral nutrition in a dose of glutamine of 0.4 g/kg/day during 7 days from admission.
干预措施: Glutamine (Combination Product)
结局指标
主要结局
ICU mortality
时间窗: 7 days
Short-term ICU mortality for patients admitted in our ICU \& signed for study drugs, who will expire during the study
次要结局
- Neutrophil/lymphocyte ratio (NLR)(7 days)
- D- dimer level(7 days)
- ICU stay(7 days)
研究者
Omar Makram Soliman
Lecturer of anesthesia and ICU
Assiut University