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临床试验/NCT05531305
NCT05531305已完成不适用

Longitudinal Changes in Muscle Mass After Intensive Care: a Pilot Feasibility Study.

Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2022年9月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
2
主要终点
Quadriceps muscle layer thickness (MLT)

研究概览

简要总结

Critically ill patients often suffer from dramatic muscle loss while in the ICU. Recovery of muscle structure and function have been proposed as core outcome measures for interventional studies in ICU survivors. Ultrasound is an accessible and validated tool to monitor muscle mass over time, with quadriceps muscle layer thickness (MLT) corresponding well to more invasive or cumbersome modalities. In order to design adequately powered studies investigating the effects of nutritional or metabolic interventions on post-ICU recovery, an estimate of the population standard deviation in MLT change over time is required. Currently there is a paucity of data describing changes in muscle mass during the subsequent period of hospitalization in ICU survivors.

The aim of this study is to estimate the mean change and standard deviation in quadriceps MLT over time, in patients discharged alive from intensive care. Patients will be followed until hospital discharge or up to 28 days after ICU discharge. Interactions with nutritional intake, inflammation and metabolic rate will be analyzed for hypothesis-generating purposes.

详细描述

Background

Rapid and severe muscle loss is a common feature in intensive care [1]. Nutritional support is provided with the intention of preventing excessive muscle protein breakdown, but the evidence that higher energy or protein intake can mitigate muscle wasting in the ICU is limited [2]. A potential explanation to these findings is the proinflammatory and catabolic state often associated with critical illness [3]. As long as a patient remains critically ill, the potential to promote anabolism and recovery may be limited.

It is well-documented that patients discharged from ICU often suffer from poor oral intake during hospital stay [4,5]. Optimizing nutritional support in the post-ICU period may therefore be a simple and cost-effective way of counteracting sarcopenia and improving health-related outcomes [6]. Currently there is a lack of published studies investigating the effect of nutritional interventions on lean body mass after intensive care. This may be due to the cumbersome and resource-intensive methods previously available for measuring body composition. In recent years, bedside ultrasound has become increasingly popular as a research tool for monitoring muscle loss over time. It has been validated against other radiological modalities, is non-invasive and accessible [7].

As there is a lack of literature describing sonographic changes in muscle mass over time in the post-ICU phase, data is needed to support a formal power calculation for interventional studies assessing muscle loss as a primary outcome measure. We therefore plan an observational longitudinal study to describe the change in quadriceps muscle layer thickness over time between ICU and hospital discharge.

Aim

研究设计

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

  • ≥18 years old.
  • ICU length of stay ≥3 days.
  • Expected to be discharged alive within 72 hours.

排除标准

  • Lack of informed consent.
  • Limitations in treatment to best supportive care (not expected to survive hospitalization).

结局指标

主要结局

Quadriceps muscle layer thickness (MLT)

时间窗: From ICU discharge to either hospital discharge or up to 28 days after ICU discharge, whichever comes first. The first measurement is performed within 72 hours after ICU discharge and repeated every 3-5 days.

Change in quadriceps MLT (mean +/- standard deviation) over time.

次要结局

  • Resting energy expenditure (REE)(From ICU discharge to either hospital discharge or up to 28 days after ICU discharge, whichever comes first. The first measurement is performed within 72 hours after ICU discharge and repeated every 3-5 days.)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Sundstrom Rehal

Principal Investigator

Karolinska University Hospital

研究点 (2)

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