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Muscle Dysfunction in Critical Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717831
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Kirby Mayer, University of Kentucky

Brief Summary:
Patients surviving critical illness suffered significant skeletal muscle dysfunction and weakness that impacts their functionality and independence. The primary purpose of this project is to develop a classification system based on the health and function of the muscle at very early time points during critical illness. The investigators will determine if muscle ultrasound can predict functional recovery at six-months post hospital discharge. Researchers will assess muscle health and function from starting day one of admission to ICU and continue until six months of recovery. In addition to muscle ultrasound, the investigators will assess muscle strength and power, and perform muscle tissue analysis on a subset of individuals. These findings will be correlated to physical function and independence at six-month follow-up.

Condition or disease Intervention/treatment
Critical Illness Intensive Care (ICU) Myopathy PICS Muscle Weakness Other: Observational study of standard of care

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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Muscle Dysfunction and Functional Outcomes in Patients With and Surviving Critical Illness
Actual Study Start Date : October 17, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 15, 2019

Group/Cohort Intervention/treatment
Healthy
Healthy subjects will be enrolled as age and activity matched controls for muscle power assessment at one time-point to establish normative values.
Other: Observational study of standard of care
Observational cohort study

ICU
Observational, subjects enrolled initially in the ICU and followed for six months after hospital discharge. ICU subdivided based on diagnosis
Other: Observational study of standard of care
Observational cohort study




Primary Outcome Measures :
  1. Physical function [ Time Frame: 6 month follow-up ]
    Gait speed measured with 4 meter (Short Performance Physical Battery)


Secondary Outcome Measures :
  1. Capacity for physical activity/exercise [ Time Frame: 6 month follow-up ]
    Distance walked during 6 minute walk test



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients admitted to ICU for critical illness with diagnosis of acute respiratory failure will be enrolled in this observational study.
Criteria

Inclusion Criteria:

  • admitted to medicine, cardio-thoracic or trauma ICU
  • initial primary or secondary diagnosis of acute respiratory distress/failure
  • mechanical ventilation (predicted for at-least 72 hours)

Exclusion Criteria:

  • receiving palliative treatment
  • attending physician excluding due to high-risk of mortality
  • neurological injury or event
  • lower extremity amputee
  • pregnant
  • non-ambulatory prior to admission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717831


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
Investigators
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Principal Investigator: Kirby Mayer, DPT, PhD(c) University of Kentucky

Publications of Results:

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Responsible Party: Kirby Mayer, Graduate Research Assistant, University of Kentucky
ClinicalTrials.gov Identifier: NCT03717831    
Other Study ID Numbers: 46072-58919
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kirby Mayer, University of Kentucky:
muscle ultrasound
post-intensive care syndrome
physical function
muscle tissue analysis
Additional relevant MeSH terms:
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Muscle Weakness
Critical Illness
Disease Attributes
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms