Critical Illness Myopathy and Trajectory of Recovery in AKI Requiring CRRT
NCT ID: NCT05287204
Last Updated: 2024-03-28
Study Results
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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ACTIVE_NOT_RECRUITING
10 participants
OBSERVATIONAL
2021-11-29
2024-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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AKI-RRT
Adults admitted to the ICU with AKI requiring CRRT with study enrollment within 48 hours of CRRT initiation.
Musculoskeletal ultrasound
Ultrasound of rectus femoris to determine cross-sectional area, muscle thickness, echo intensity.
Assessments of muscle strength and physical function
A battery of tests of physical function and muscle strength (see outcomes section for details).
Metabolomics
Using metabolomic analysis, concentrations of amino acids and other important analytes will be measured in patient plasma and CRRT effluent
Historical Controls
The controls for the ICU phase will be 41 critically ill adults without AKI-RRT in whom similar measurements of muscle size, quality, and function were collected in a recent prior study \[PubMed ID: 33148301\]. The controls for the recovery phase will come from an ongoing prospective observational study being performed at the University of Kentucky, which will include outpatient functional assessments performed on 200 ICU survivors (NCT05537298).
Musculoskeletal ultrasound
Ultrasound of rectus femoris to determine cross-sectional area, muscle thickness, echo intensity.
Assessments of muscle strength and physical function
A battery of tests of physical function and muscle strength (see outcomes section for details).
Interventions
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Musculoskeletal ultrasound
Ultrasound of rectus femoris to determine cross-sectional area, muscle thickness, echo intensity.
Assessments of muscle strength and physical function
A battery of tests of physical function and muscle strength (see outcomes section for details).
Metabolomics
Using metabolomic analysis, concentrations of amino acids and other important analytes will be measured in patient plasma and CRRT effluent
Eligibility Criteria
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Inclusion Criteria
* AKI requiring CRRT, with enrollment within 48 hours of CRRT initiation
Exclusion Criteria
* RRT of any kind at any time prior to ICU admission
* Chronic kidney disease (CKD) with estimated glomerular filtration rate \<20 mL/min/1.73 m2 as calculated by the 2021 CKD-EPI equation
* underlying muscle disorders or muscle atrophy such as quadriplegia or hemiplegia, stroke with residual motor deficits, end-stage liver disease, active alcohol use disorder, active malignancy (other than non-melanoma skin cancer) within 1 year, burns, or other baseline neuromuscular disease
* pregnancy
* concomitant use of other extracorporeal support devices such as ventricular assist devices or extracorporeal membrane oxygenation
* anticipated inability to engage in weight-bearing testing after discharge (e.g., trauma or orthopedic surgery)
* subjects will be ineligible for outpatient testing if they remain on RRT in the week prior to the research appointment
18 Years
89 Years
ALL
No
Sponsors
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University of Iowa
OTHER
Responsible Party
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Benjamin Griffin
Assistant Professor
Locations
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University of Iowa
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
University of New Mexico
Albuquerque, New Mexico, United States
Countries
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References
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Teixeira JP, Mayer KP, Griffin BR, George N, Jenkins N, Pal CA, Gonzalez-Seguel F, Neyra JA. Intensive Care Unit-Acquired Weakness in Patients With Acute Kidney Injury: A Contemporary Review. Am J Kidney Dis. 2023 Mar;81(3):336-351. doi: 10.1053/j.ajkd.2022.08.028. Epub 2022 Nov 2.
Mayer KP, Thompson Bastin ML, Montgomery-Yates AA, Pastva AM, Dupont-Versteegden EE, Parry SM, Morris PE. Acute skeletal muscle wasting and dysfunction predict physical disability at hospital discharge in patients with critical illness. Crit Care. 2020 Nov 4;24(1):637. doi: 10.1186/s13054-020-03355-x.
Mayer KP, Welle MM, Evans CG, Greenhill BG, Montgomery-Yates AA, Dupont-Versteegden EE, Morris PE, Parry SM. Muscle Power is Related to Physical Function in Patients Surviving Acute Respiratory Failure: A Prospective Observational Study. Am J Med Sci. 2021 Mar;361(3):310-318. doi: 10.1016/j.amjms.2020.09.018. Epub 2020 Oct 3.
Mayer KP, Dhar S, Cassity E, Denham A, England J, Morris PE, Dupont-Versteegden EE. Interrater Reliability of Muscle Ultrasonography Image Acquisition by Physical Therapists in Patients Who Have or Who Survived Critical Illness. Phys Ther. 2020 Aug 31;100(9):1701-1711. doi: 10.1093/ptj/pzaa068.
Mayer KP, Ortiz-Soriano VM, Kalantar A, Lambert J, Morris PE, Neyra JA. Acute kidney injury contributes to worse physical and quality of life outcomes in survivors of critical illness. BMC Nephrol. 2022 Apr 7;23(1):137. doi: 10.1186/s12882-022-02749-z.
Mayer KP, Teixeira JP, Gonzalez-Seguel F, Tran VQ, Gross JM, Horikawa-Strakovsky A, Pal CA, Shareef ZT, Puffer Israel H, Wen Y, Griffin BR, Neyra JA. Acute skeletal muscle wasting in patients with acute kidney injury requiring continuous kidney replacement therapy: A prospective multicenter study. J Crit Care. 2025 Oct;89:155142. doi: 10.1016/j.jcrc.2025.155142. Epub 2025 Jun 12.
Gonzalez-Seguel F, Tran VQ, Pal CA, Shareef ZT, Israel HP, Horikawa-Strakovsky A, Wen Y, Griffin BR, Neyra JA, Teixeira JP, Mayer KP. Inter-rater reliability of muscle ultrasonography performed by multidisciplinary novice sonographers in the evaluation of critically ill patients with acute kidney injury requiring continuous kidney replacement therapy. Ren Fail. 2025 Dec;47(1):2472990. doi: 10.1080/0886022X.2025.2472990. Epub 2025 Mar 11.
Teixeira JP, Griffin BR, Pal CA, Gonzalez-Seguel F, Jenkins N, Jones BM, Yoshida Y, George N, Israel HP, Ghazi L, Neyra JA, Mayer KP. Critical illness myopathy and trajectory of recovery in acute kidney injury requiring continuous renal replacement therapy: a prospective observational trial protocol. BMJ Open. 2023 May 22;13(5):e072448. doi: 10.1136/bmjopen-2023-072448.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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202002328
Identifier Type: -
Identifier Source: org_study_id
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