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临床试验/NCT04909905
NCT04909905已完成3 期

The Impact of Glutamine Supplementation Upon the Short-term Mortality of COVID-19 Diseased Patients Admitted in ICU: A Double Blind Randomized Clinical Trial

Assiut University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月30日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Makram Soliman

Lecturer of anesthesia and ICU

Assiut University

研究点 (2)

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