Critical Illness Myopathy and Trajectory of Recovery in AKI Requiring CRRT

NCT ID: NCT05287204

Last Updated: 2024-03-28

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

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-29

Study Completion Date

2024-12-30

Brief Summary

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The purpose of this study is to determine whether patients with acute kidney injury requiring renal replacement therapy have a higher incidence of muscle wasting than controls and whether the course of recovery is longer compared to controls.

Detailed Description

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Acute kidney injury (AKI), the abrupt loss of kidney function, is a common complication that affects more than half of all intensive care unit (ICU) admissions, and it is associated with substantially higher rates of morbidity and mortality in both the short- and the long-term. This is especially true in patients with AKI requiring renal replacement therapy (AKI-RRT), also known as dialysis. An understudied mechanism by which AKI-RRT may contribute to poor clinical outcomes, both in the hospital and after discharge, is through its impact on muscle mass and muscle function. AKI of any severity is known to alter tissue utilization of amino acids, and preliminary data suggest that RRT in the ICU may exacerbate muscle dysfunction through the removal of large quantities of amino acids from the patient's plasma. This study will determine whether patients with AKI-RRT have greater lean muscle loss over 1 week than historical critically ill controls, whether patients with AKI-RRT have diminished recovery of muscle mass and function at 1-3 months following discharge compared to controls, and whether changes in plasma levels of amino acids during hospitalization correlate with loss of muscle function or lack of recovery.

Conditions

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Acute Kidney Injury Critical Illness Myopathy Dialysis; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Ultrasound of rectus femoris to determine cross-sectional area, muscle thickness, echo intensity.

Assessments of muscle strength and physical function

Intervention Type DIAGNOSTIC_TEST

A battery of tests of physical function and muscle strength (see outcomes section for details).

Metabolomics

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Ultrasound of rectus femoris to determine cross-sectional area, muscle thickness, echo intensity.

Assessments of muscle strength and physical function

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Assessments of muscle strength and physical function

A battery of tests of physical function and muscle strength (see outcomes section for details).

Intervention Type DIAGNOSTIC_TEST

Metabolomics

Using metabolomic analysis, concentrations of amino acids and other important analytes will be measured in patient plasma and CRRT effluent

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* \>18 years old
* AKI requiring CRRT, with enrollment within 48 hours of CRRT initiation

Exclusion Criteria

* ICU admission for \>7 days
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Griffin

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 36332719 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33148301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33189316 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32302406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35392844 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40513259 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40069097 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37217272 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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202002328

Identifier Type: -

Identifier Source: org_study_id

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