Clinical trial NCT04849624: Body Composition Study in Critically Ill Patients-Extended to COVID-19
Official title: Body Composition Study in Critically Ill Patients-Extended to COVID-19
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Critical Illness
Covid19
Muscle Atrophy
Muscle Strength
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 30 COVID-19 ICU patients as per the eligibility criteria will be recruited. A total of 20 non-COVID-19 ICU patients that are matched by age (+/- 10 years old), sex and ventilation mode (mostly will be with lung pathology) will be enrolled to compare their change in muscle mass and muscle strength at hospital discharge with COVID-19 ICU patients.

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

Eligibility criteria: 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

Primary outcomes:
measure: Rectus Femoris Thickness
timeFrame: Change in Rectus Femoris Thickness at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)
measure: Rectus Femoris Cross-sectional Area
timeFrame: 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 outcomes:
measure: Forearm Muscle Thickness
timeFrame: Change in Forearm Muscle Thickness at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)
measure: Handgrip Strength
timeFrame: Before Hospital Discharge
measure: Knee Extension Strength
timeFrame: Before Hospital Discharge
Other outcomes:
measure: Mortality
timeFrame: Mortality at day 28 (calculated from the first day of ICU admission)
measure: ICU length of stay
timeFrame: From date of enrolment until the date of discharged from the ICU, assessed up to 60 days
measure: Hospital length of stay
timeFrame: From date of enrolment until the date of discharged from the hospital, assessed up to 60 days
measure: Length of Mechanical Ventilation
timeFrame: From date of commencement of mechanical ventilation until the date of liberation from mechanical ventilation, assessed up to 60 days
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Faculty of Medicine, University of Malaya
Study officials:
References:
citation: 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.