跳至主要内容
临床试验/NCT04522388
NCT04522388终止不适用

A Pilot Study Examining the Effect of Nutritional Supplementation on Skeletal Muscle Mass in Patients Awaiting Lung Transplant

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
2
主要终点
Effect of nutritional supplementation on skeletal muscle mass as assessed by ultrasound of the quadriceps

研究概览

简要总结

This non-randomized pilot study aims to investigate whether a protein rich nutritional shake (Ensure Enlive) given to patients pre-transplant will decrease skeletal muscle loss (measured by quadriceps ultrasound) and improve nutritional state (measured by Nutritional Risk Index). A nutritional supplement would be a cost-effective solution to treat malnutrition, a known risk factor implicated in poor outcomes for lung transplant recipients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Subjects 18 years or older who are listed for single or double lung transplant
  • Subject provides written informed consent to participate in this study

排除标准

  • Subject with history of Galactosemia
  • Subject with history of milk protein allergy
  • Subject with history of soy protein allergy

结局指标

主要结局

Effect of nutritional supplementation on skeletal muscle mass as assessed by ultrasound of the quadriceps

时间窗: Pre-transplant

To examine the effect of nutritional supplementation on skeletal muscle mass in patients with end stage lung disease who are awaiting lung transplant, measured by ultrasound of the quadriceps.

次要结局

  • Effect of nutritional supplementation on Nutritional Risk index as assessed by serum albumin level(Pre-transplant)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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