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

NCT ID: NCT04849624

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-05

Study Completion Date

2025-06-01

Brief Summary

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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

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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

Conditions

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Critical Illness Covid19 Muscle Atrophy Muscle Strength

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ICU COVID-19 patients

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

No Intervention

Intervention Type OTHER

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

No Intervention

Intervention Type OTHER

This is an observational study and involved no intervention

Interventions

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No Intervention

This is an observational study and involved no intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Medicine, University of Malaya

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type BACKGROUND
PMID: 32919818 (View on PubMed)

Other Identifiers

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2019615-7520-3

Identifier Type: -

Identifier Source: org_study_id

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