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

Sponsor
University of Malaya (Other)
Overall Status
Recruiting
CT.gov ID
NCT04849624
Collaborator
(none)
50
1
22.9
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No Intervention

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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Body Composition Study in Critically Ill Patients-Extended to COVID-19
Actual Study Start Date :
Mar 5, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
ICU COVID-19 patients

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Secondary Outcome Measures

  1. 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

  2. Handgrip Strength [Before Hospital Discharge]

    BIlateral Handgrip Strength

  3. Knee Extension Strength [Before Hospital Discharge]

    BIlateral Knee Extension Strength

Other Outcome Measures

  1. Mortality [Mortality at day 28 (calculated from the first day of ICU admission)]

    28-day Mortality

  2. ICU length of stay [From date of enrolment until the date of discharged from the ICU, assessed up to 60 days]

    Length of stay in the ICU

  3. Hospital length of stay [From date of enrolment until the date of discharged from the hospital, assessed up to 60 days]

    Length of stay in the Hospital

  4. Length of Mechanical Ventilation [From date of commencement of mechanical ventilation until the date of liberation from mechanical ventilation, assessed up to 60 days]

    Duration of Mechanical Ventilation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine, University of Malaya Kuala Lumpur Malaysia 50603

Sponsors and Collaborators

  • University of Malaya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Malaya
ClinicalTrials.gov Identifier:
NCT04849624
Other Study ID Numbers:
  • 2019615-7520-3
First Posted:
Apr 19, 2021
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022