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

Active, not recruiting

• Conditions: Covid19; Muscle Atrophy; Critical Illness; Muscle Strength
• Interventions: Other: No Intervention

• Registration Number: NCT04849624
• Lead Sponsor: University of Malaya

Brief Summary

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.

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

Study Timeline

• Study Start: 2021-03-05
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-04-15
• Study First Posted: 2021-04-19
• Primary Completion: 2024-06-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU non-COVID-19 patients	No Intervention	Non-COVID-19 patients that are admitted into the ICU matched with ICU COVID-19 patients that are recruited and fulfilled the eligibility criteria
ICU COVID-19 patients	No Intervention	COVID-19 patients that are admitted into the ICU and fulfilled the eligibility criteria

Primary Outcome Measures

Name	Time	Method
Rectus Femoris Cross-sectional Area	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	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

Secondary Outcome Measures

Name	Time	Method
Knee Extension Strength	Before Hospital Discharge	BIlateral Knee Extension Strength
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)	Change in Forearm Muscle Thickness
Handgrip Strength	Before Hospital Discharge	BIlateral Handgrip Strength

Trial Locations

Locations (1)

Faculty of Medicine, University of Malaya; 🇲🇾 Kuala Lumpur, Malaysia