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临床试验/NCT04249050
NCT04249050Unknown不适用

Effects of Immunonutrition on the Acute Immune Response in Hospitalized Patients With Pneumonia

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年3月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Interleukin-6

研究概览

简要总结

The project is a randomized controlled trial taking place in the North Zealand hospital in the city Hilleroed, Denmark.

The aim is to investigate the potential beneficial effects of immunonutrition containing fish oil, arginine and RNA, on the acute immune response in patients with pneumonia.

详细描述

Immunonutrition has a well-documented beneficial effect on surgical patients by strengthening the immune system and reducing the following: inflammation, the number of infections as well as hospitalization time. A study in operated patients demonstrated the benefit of immunonutrition by reducing unwanted inflammation, measured by the pro-inflammatory signalling protein, interleukin-6. The same study saw a smaller decrease in immune function (measured as the level of phagocytosis) in the group receiving immunonutrition than in the control group. This project will investigate whether similar effects can be detected in patients with pneumonia.

The project is being carried out in a collaboration between the University of Copenhagen, The main hospital of Copenhagen (Rigshospitalet) and North Zealand Hospital. The project is a randomized clinical intervention study, which spans 10 days. Participants are allocated to the intervention group or the control group. The project is being carried out at the North Zealand hospital, at the Department of Pulmonary- and Infectious Diseases.

The intervention group receives the department's standard treatment (Standard Of Care) + immunonutrition, while the control group receives the hospital department's standard treatment (Standard Of Care). On a daily basis, the patient's clinical condition and the activity of the immune system is measured for the purpose of determine whether there is an effect of immunonutrition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • Authorized individuals diagnosed with pneumonia who speak and write in danish

排除标准

  • individuals with Immunodeficiency
  • individuals with another primary diagnose
  • individuals with an allergy against product ingredients
  • individuals with dementia
  • individuals with dysphagia
  • individuals with cancer in treatment
  • individuals with Chronic Obstructive Pulmonary Disease on continuing steroid treatment or home administered oxygen treatment

结局指标

主要结局

Interleukin-6

时间窗: daily measure from first day of inclusion until discharge (maximum 10 days)

Measure of the acute immune response

次要结局

  • Length of stay(From admittance to discharge (maximum 10 days))
  • Hand grip strength(Daily from admittance to discharge (maximum 10 days))

研究者

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

Jens Rikardt Andersen

Associate Professor

University of Copenhagen

研究点 (2)

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