Muscle Recovery After Critical Illness

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Kirby Mayer
Study ID
NCT05537298
Status
Recruiting
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Conditions

  • Critical Illness
  • ICU Acquired Weakness
  • Muscle Weakness
  • Post Intensive Care Unit Syndrome

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The overarching goal of the proposed study is to determine the trajectories of physical recovery and cellular markers involved with the underlying failure to recover muscle after critical illness, while exploring which characteristics are associated with sustained physical disability. This proposal will examine muscle pathophysiology carefully aligned with physical function outcomes in order to longitudinally assess the recovery, or failed recovery, of muscle function in participants after critical illness: 1. to examine the recovery of muscle and physical function in ICU survivors through longitudinal assessments 2. to investigate the underlying cellular markers and mechanisms of muscle recovery in ICU survivors 3. to determine which cellular markers contribute to physical disability in ICU survivors up to 1 year after hospital admission

Key Dates

Start date
Oct 18, 2022
Status verified
Jun 2026
Primary completion
Jul 2, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
209 participants (estimated)

Arms

  • Arm: Survivor
    Patients (n = 209) surviving critical illness will be enrolled to longitudinal, observational study examining muscle strength, power, and fatigue as well as physical function at hospital discharge and repeated at 3-, 6-, and 12-month following. A subset of individuals (n =32) will undergo muscle biopsies and blood will be collected.
  • Arm: Control
    A group of healthy controls will be recruited to serve as comparator to measures of strength, power, physical function, and muscle tissue analyses. Controls will participate in a one-time assessment.

Primary Outcome Measure

Physical function [ Time Frame: the change from baseline to 12-months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35005-
University of KentuckyLexingtonKentucky40536
Kirby Mayer, DPT, PhD
[email protected]
8593233863
Esther E Dupont-Versteegden, PhD (PRINCIPAL_INVESTIGATOR)
Ashley A Montgomery-Yates, MD (SUB_INVESTIGATOR)
Anna G. Kalema, MD (SUB_INVESTIGATOR)
Jamie L Sturgill, PhD (SUB_INVESTIGATOR)
Philip Kern, MD (SUB_INVESTIGATOR)
Oklahoma Medical Research FoundationOklahoma CityOklahoma73113-

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