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

NCT04849624 | Active Not Recruiting

• 1 other identifier: 2019615-7520-3
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Covid19; Muscle Atrophy; Muscle Strength

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• 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

Other Outcomes (4)

• Mortality

  Mortality at day 28 (calculated from the first day of ICU admission)

• ICU length of stay

  From date of enrolment until the date of discharged from the ICU, assessed up to 60 days

• Hospital length of stay

  From date of enrolment until the date of discharged from the hospital, assessed up to 60 days

Study Arms (2)

ICU COVID-19 patients

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

Other: No Intervention

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

Other: No Intervention

Interventions

No Intervention OTHER

This is an observational study and involved no intervention

ICU COVID-19 patients; ICU non-COVID-19 patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Medicine, University of Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related 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.

  PMID: 32919818 BACKGROUND

MeSH Terms

Conditions

Critical Illness; COVID-19; Muscular Atrophy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: April 19, 2021
• Study Start: March 5, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

MY (1)