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

Covid19 Clinical Trial

— COVID-MUSCLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04849624
• Other study ID #: 2019615-7520-3
• Status: Recruiting
• Start date: March 5, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2023
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Critical Illness
• Muscle Atrophy
• Muscle Strength
• Muscular Atrophy

Intervention

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

Locations

Country	Name	City	State
Malaysia	Faculty of Medicine, University of Malaya	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	28-day Mortality	Mortality at day 28 (calculated from the first day of ICU admission)
Other	ICU length of stay	Length of stay in the ICU	From date of enrolment until the date of discharged from the ICU, assessed up to 60 days
Other	Hospital length of stay	Length of stay in the Hospital	From date of enrolment until the date of discharged from the hospital, assessed up to 60 days
Other	Length of Mechanical Ventilation	Duration of Mechanical Ventilation	From date of commencement of mechanical ventilation until the date of liberation from mechanical ventilation, assessed up to 60 days
Primary	Rectus Femoris Thickness	Change in 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)
Primary	Rectus Femoris Cross-sectional Area	Change in 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)
Secondary	Forearm Muscle Thickness	Change in 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)
Secondary	Handgrip Strength	BIlateral Handgrip Strength	Before Hospital Discharge
Secondary	Knee Extension Strength	BIlateral Knee Extension Strength	Before Hospital Discharge