Clinical trial NCT05287204: Critical Illness Myopathy and Trajectory of Recovery in AKI Requiring CRRT
Official title: Critical Illness Myopathy and Trajectory of Recovery in Acute Kidney Injury (AKI) Requiring Continuous Renal Replacement Therapy (CRRT): A Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Kidney Injury
Critical Illness Myopathy
Dialysis; Complications
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be composed of critically ill patients with acute kidney injury requiring continuous renal replacement therapy in an ICU setting.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: ICU Stage: rectus femoris (RF) cross-sectional area (CSA)
timeFrame: 7 days
measure: ICU Stage: RF muscle thickness (mT)
timeFrame: 7 days
measure: ICU Stage: RF echo intensity (EI)
timeFrame: 7 days
measure: RF CSA at discharge
timeFrame: 1 month
measure: RF mT at discharge
timeFrame: 1 month
measure: RF EI at discharge
timeFrame: 1 month
measure: RF CSA at post-discharge outpatient visit
timeFrame: 1-3 months
measure: RF mT at post-discharge outpatient visit
timeFrame: 1-3 months
measure: RF EI at post-discharge outpatient visit
timeFrame: 1-3 months
measure: ICU Stage: ICU Mobility Scale
timeFrame: 7 days
measure: Muscle Strength - Medical Research Council Sum-score (MRC-ss) at discharge
timeFrame: 1 month
measure: Muscle Strength - MRC-ss at post-discharge outpatient visit
timeFrame: 1-3 months
measure: Muscle Strength - knee extension by hand-held dynamometry (HHD) at hospital discharge
timeFrame: 1 month
measure: Muscle Strength - knee extension by HHD at post-discharge outpatient visit
timeFrame: 1-3 months
measure: Muscle Strength - Grip Strength at hospital discharge
timeFrame: 1 month
measure: Muscle Strength - Grip Strength at post-discharge outpatient visit
timeFrame: 1-3 months
measure: Physical Function - Short Physical Performance Battery (SPPB) at discharge
timeFrame: 1 month
measure: Physical Function - SPPB at post-discharge outpatient visit
timeFrame: 1-3 months
measure: TUG Test at post-discharge outpatient visit
timeFrame: 1-3 months
measure: Physical Function - 6-minute walk test (6MWT) at post-discharge outpatient visit
timeFrame: 1-3 months
measure: Quality of Life testing using EuroQol Group 5-dimension 5-level (EQ-5D-5L) questionnaire at post-discharge outpatient visit
timeFrame: 1-3 months
measure: Physical Function - Clinical Frailty Scale (CFS) at post-discharge outpatient visit
timeFrame: 1-3 months
measure: Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Questionnaire at post-discharge outpatient visit
timeFrame: 1-3 months
measure: 36-Item Short Form Health Survey Physical Function Scale (SF-36) at post-discharge outpatient visit
timeFrame: 1-3 months
measure: Return to driving
timeFrame: 1-3 months
measure: Return to work or hobby
timeFrame: 1-3 months
measure: Hospital Readmission
timeFrame: 1-3 months
measure: Emergency Department Visit
timeFrame: 1-3 months
Secondary outcomes:
measure: ICU Stage: Changes in Plasma Metabolome
timeFrame: 7 days
measure: ICU Stage: Changes in CRRT Effluent Metabolome
timeFrame: 7 days
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.