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临床试验/NCT04849624
NCT04849624已完成不适用

Body Composition Study in Critically Ill Patients-Extended to COVID-19

University of Malaya2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2021年3月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Rectus Femoris Cross-sectional Area

研究概览

简要总结

Muscle loss (ultrasound quadricep muscle) and muscle strength (handgrip and knee extension strength) will be compared between COVID-19 and non COVID-19 critically ill patients.

详细描述

Given the heightened inflammatory status among COVID-19 critically ill patients, we hypothesized that the rate of skeletal muscle loss is accelerated in this population, and this loss is even more pronounce than the general critically ill patients. We further hypothesized that the increased muscle loss will lead to worse functional outcome (lower muscle strength) in COVID-19 critically ill patients compared with age- and sex-matched non-COVID-19 critically ill patients, as it has been shown that quadriceps thickness is strongly correlated with functional status at ICU discharge. Furthermore, a recent systematic review and meta-analysis in survivors of coronavirus (severe acute respiratory syndrome, SARS or Middle-east respiratory syndrome, MERS, or COVID-19) also demonstrated reduced exercise capacity and quality of life at 6 months after hospitalization or ICU admission

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 18 years old
  • Admitted into the ICU due to COVID-19

排除标准

  • Likely to transfer out from the ICU in 24 hours from screening
  • Likely to die in the next 7 days
  • Bedbound prior to hospital admission or bedbound in the hospital for >10 days

研究组 & 干预措施

ICU COVID-19 patients

COVID-19 patients that are admitted into the ICU and fulfilled the eligibility criteria

干预措施: No Intervention (Other)

ICU non-COVID-19 patients

Non-COVID-19 patients that are admitted into the ICU matched with ICU COVID-19 patients that are recruited and fulfilled the eligibility criteria

干预措施: No Intervention (Other)

结局指标

主要结局

Rectus Femoris Cross-sectional Area

时间窗: Change in Rectus Femoris Cross-sectional Area at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)

Change in Rectus Femoris Cross-sectional Area

Rectus Femoris Thickness

时间窗: Change in Rectus Femoris Thickness at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)

Change in Rectus Femoris Thickness

次要结局

  • Forearm Muscle Thickness(Change in Forearm Muscle Thickness at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission))
  • Handgrip Strength(Before Hospital Discharge)
  • Knee Extension Strength(Before Hospital Discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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