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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 1, 2024

Detailed Description

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

Interventions

  • Other: No Intervention
    • This is an observational study and involved no intervention

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Rectus Femoris Thickness
    • Time Frame: 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
  • Rectus Femoris Cross-sectional Area
    • Time Frame: 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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • ≥ 18 years old – Admitted into the ICU due to COVID-19 Exclusion Criteria:

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Malaya
  • Provider of Information About this Clinical Study
    • Sponsor

References

Lee ZY, Ong SP, Ng CC, Yap CSL, Engkasan JP, Barakatun-Nisak MY, Heyland DK, Hasan MS. Association between ultrasound quadriceps muscle status with premorbid functional status and 60-day mortality in mechanically ventilated critically ill patient: A single-center prospective observational study. Clin Nutr. 2021 Mar;40(3):1338-1347. doi: 10.1016/j.clnu.2020.08.022. Epub 2020 Aug 28.

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