Acute Kidney InjuryNCT05287204
Critical Illness Myopathy and Trajectory of Recovery in AKI Requiring CRRT
An observational study of Acute Kidney Injury and Critical Illness Myopathy, run by University of Iowa at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Acute Kidney Injury, Critical Illness Myopathy, Dialysis; Complications
- What is being tested?
- Musculoskeletal ultrasound, Assessments of muscle strength and physical function and Metabolomics
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Nov 2021to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- >18 years old
- AKI requiring CRRT, with enrollment within 48 hours of CRRT initiation
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of New Mexico
Albuquerque, New Mexico, 87106
University of Iowa
Iowa City, Iowa, 52242
University of Kentucky
Lexington, Kentucky, 40506
About this study
Official title: Critical Illness Myopathy and Trajectory of Recovery in Acute Kidney Injury (AKI) Requiring Continuous Renal Replacement Therapy (CRRT): A Prospective Observational Trial
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.
Read the 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.
- Being tested
- Musculoskeletal ultrasound, Assessments of muscle strength and physical function, Metabolomics
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musculoskeletal ultrasoundDiagnostic test
Ultrasound of rectus femoris to determine cross-sectional area, muscle thickness, echo intensity.
Assessments of muscle strength and physical functionDiagnostic test
A battery of tests of physical function and muscle strength (see outcomes section for details).
MetabolomicsDiagnostic test
Using metabolomic analysis, concentrations of amino acids and other important analytes will be measured in patient plasma and CRRT effluent
| Study group | Role | What they receive |
|---|---|---|
| AKI-RRT | Adults admitted to the ICU with AKI requiring CRRT with study enrollment within 48 hours of CRRT initiation. Receives: Diagnostic Test: Musculoskeletal ultrasound; Diagnostic Test: Assessments of muscle strength and physical function; Diagnostic Test: Metabolomics | |
| 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). Receives: Diagnostic Test: Musculoskeletal ultrasound; Diagnostic Test: Assessments of muscle strength and physical function |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Stage: rectus femoris (RF) cross-sectional area (CSA)
RF CSA as assessed by musculoskeletal ultrasound (MSKUS) will be measured at day 0 (study enrollment within 48 hours of CRRT initiation), at day 3, and at day 7 (or at ICU discharge if before day 7).
Measured: 7 days
ICU Stage: RF muscle thickness (mT)
RF mT as assessed by MSKUS will be measured at day 0 (study enrollment within 48 hours of CRRT initiation), at day 3, and at day 7 (or at ICU discharge if before day 7).
Measured: 7 days
ICU Stage: RF echo intensity (EI)
RF EI as assessed by MSKUS will be measured at day 0 (study enrollment within 48 hours of CRRT initiation), at day 3, and at day 7 (or at ICU discharge if before day 7).
Measured: 7 days
RF CSA at discharge
RF CSA as assessed by MSKUS will be measured at hospital discharge.
Measured: 1 month
RF mT at discharge
RF mT as assessed by MSKUS will be measured at hospital discharge.
Measured: 1 month
RF EI at discharge
RF EI as assessed by MSKUS will be measured at hospital discharge.
Measured: 1 month
RF CSA at post-discharge outpatient visit
RF CSA as assessed by MSKUS will be measured at outpatient follow-up visit.
Measured: 1-3 months
RF mT at post-discharge outpatient visit
RF mT as assessed by MSKUS will be measured at outpatient follow-up visit.
Measured: 1-3 months
RF EI at post-discharge outpatient visit
RF mT as assessed by MSKUS will be measured at outpatient follow-up visit.
Measured: 1-3 months
ICU Stage: ICU Mobility Scale
The ICU Mobility Scale is an 11-point scale ranging from 0-10 which involves scoring a patient's maximum level of mobility in the prior 24-hour period. The ICU Mobility Scale will be performed at the same 3 time points as the MSKUS assessments.
Measured: 7 days
Muscle Strength - Medical Research Council Sum-score (MRC-ss) at discharge
MRC-ss is a measure of global peripheral muscle strength that is the current clinical standard for diagnosing ICU-acquired weakness. Muscle strength is assessed by physical exam and rated on an ordinal scale (0-5) at six bilateral muscle groups: shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors.
Measured: 1 month
Muscle Strength - MRC-ss at post-discharge outpatient visit
MRC-ss is a measure of global peripheral muscle strength that is the current clinical standard for diagnosing ICU-acquired weakness. Muscle strength is assessed by physical exam and rated on an ordinal scale (0-5) at six bilateral muscle groups: shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors.
Measured: 1-3 months
Muscle Strength - knee extension by hand-held dynamometry (HHD) at hospital discharge
Maximal isometric knee extensor muscle strength as measured by HHD.
Measured: 1 month
Muscle Strength - knee extension by HHD at post-discharge outpatient visit
Maximal isometric knee extensor muscle strength as measured by HHD.
Measured: 1-3 months
Muscle Strength - Grip Strength at hospital discharge
Maximal isometric grip strength as measured by hand-grip dynamometry (HGD)
Measured: 1 month
Muscle Strength - Grip Strength at post-discharge outpatient visit
Maximal isometric grip strength as measured by HGD
Measured: 1-3 months
Physical Function - Short Physical Performance Battery (SPPB) at discharge
SPPB is a performance-based composite test with a total of 12 points including components of balance (side-by-side stand, semi-tandem stand, and full-tandem stand), chair-to-stand test, and 4-meter habitual gait speed used to assess physical function and physical frailty.
Measured: 1 month
Physical Function - SPPB at post-discharge outpatient visit
SPPB is a performance-based composite test with a total of 12 points including components of balance (side-by-side stand, semi-tandem stand, and full-tandem stand), chair-to-stand test, and 4-meter habitual gait speed used to assess physical function and physical frailty.
Measured: 1-3 months
TUG Test at post-discharge outpatient visit
The Timed Up and Go (TUG) test assesses the time (in seconds) for a subject to stand on command from a seated position, walk 3 meters, turn around, walk back to the chair, and sit down, thereby assessing mobility, physical function, and fall risk.
Measured: 1-3 months
Physical Function - 6-minute walk test (6MWT) at post-discharge outpatient visit
The 6MWT assesses the distance a subject can walk in six minutes, providing a global representation of physical function and cardiopulmonary endurance.
Measured: 1-3 months
Quality of Life testing using EuroQol Group 5-dimension 5-level (EQ-5D-5L) questionnaire at post-discharge outpatient visit
The EQ-5D-5L is a standardized measure of health status developed by the Euro-Qol Group to provide an assessment of health for clinical and economic appraisal.
Measured: 1-3 months
Physical Function - Clinical Frailty Scale (CFS) at post-discharge outpatient visit
CFS is a widely adopted judgement-based tool to screen for frailty and to broadly stratify degrees of fitness and frailty.
Measured: 1-3 months
Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Questionnaire at post-discharge outpatient visit
The FACIT-F scale is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function.
Measured: 1-3 months
36-Item Short Form Health Survey Physical Function Scale (SF-36) at post-discharge outpatient visit
The SF-36 is a 36-item patient-reported survey of health commonly used to evaluate adult patients which contains 8 domains, including a physical function scale based on 10 of the 36 items which has been shown to have high reliability.
Measured: 1-3 months
Return to driving
Yes / No outcome assessed at the outpatient follow-up visit
Measured: 1-3 months
Return to work or hobby
Yes / No outcome assessed at the outpatient follow-up visit
Measured: 1-3 months
Hospital Readmission
Yes / No outcome assessed at the outpatient follow-up visit
Measured: 1-3 months
Emergency Department Visit
Yes / No outcome assessed at the outpatient follow-up visit
Measured: 1-3 months
Secondary outcomes (2)
ICU Stage: Changes in Plasma Metabolome
Plasma samples will be obtained at day 0 (study enrollment within 48 hours of CRRT initiation), at day 3, and at day 7 (or at ICU discharge if before day 7) and metabolomic analysis will be performed to determine if changes in the plasma metabolome with CRRT initiation correlate with parameters of muscle wasting and/or trajectory of recovery of muscle weakness.
Measured: 7 days
ICU Stage: Changes in CRRT Effluent Metabolome
CRRT effluent samples will be obtained at day 0 (study enrollment within 48 hours of CRRT initiation), at day 3, and at day 7 (or at ICU discharge if before day 7) and metabolomic analysis will be performed to determine if changes in the effluent metabolome with CRRT initiation correlate with parameters of muscle wasting and/or trajectory of recovery of muscle weakness.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start29 Nov 2021
- Primary completion30 Sep 2023
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Griffin, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287204
- Sponsor's protocol ID
- 202002328
- Status last verified
- Mar 2024
- First submitted
- 20 Oct 2021
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36332719Mayer 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.
PubMed 33148301Mayer 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.
PubMed 33189316Mayer 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.
PubMed 32302406Mayer 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.
PubMed 35392844Mayer 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.
PubMed 40513259Gonzalez-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.
PubMed 40069097Teixeira 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.
PubMed 37217272
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Illness Myopathy and Trajectory of Recovery in Acute Kidney Injury (AKI) Requiring Continuous Renal Replacement Therapy (CRRT): A Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT05287204
- Acronym / sponsor ID
- 202002328
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI-RRT | – | Diagnostic Test: Musculoskeletal ultrasound, Diagnostic Test: Assessments of muscle strength and physical function, Diagnostic Test: MetabolomicsAdults admitted to the ICU with AKI requiring CRRT with study enrollment within 48 hours of CRRT initiation. |
| Historical Controls | – | Diagnostic Test: Musculoskeletal ultrasound, Diagnostic Test: Assessments of muscle strength and physical functionThe 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). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- >18 years old
- AKI requiring CRRT, with enrollment within 48 hours of CRRT initiation
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musculoskeletal ultrasoundUltrasound of rectus femoris to determine cross-sectional area, muscle thickness, echo intensity. | Diagnostic test | AKI-RRT, Historical Controls |
| Assessments of muscle strength and physical functionA battery of tests of physical function and muscle strength (see outcomes section for details). | Diagnostic test | AKI-RRT, Historical Controls |
| MetabolomicsUsing metabolomic analysis, concentrations of amino acids and other important analytes will be measured in patient plasma and CRRT effluent | Diagnostic test | AKI-RRT |
Primary outcome
ICU Stage: rectus femoris (RF) cross-sectional area (CSA)
Time frame: 7 days
RF CSA as assessed by musculoskeletal ultrasound (MSKUS) will be measured at day 0 (study enrollment within 48 hours of CRRT initiation), at day 3, and at day 7 (or at ICU discharge if before day 7).
ICU Stage: RF muscle thickness (mT)
Time frame: 7 days
RF mT as assessed by MSKUS will be measured at day 0 (study enrollment within 48 hours of CRRT initiation), at day 3, and at day 7 (or at ICU discharge if before day 7).
ICU Stage: RF echo intensity (EI)
Time frame: 7 days
RF EI as assessed by MSKUS will be measured at day 0 (study enrollment within 48 hours of CRRT initiation), at day 3, and at day 7 (or at ICU discharge if before day 7).
RF CSA at discharge
Time frame: 1 month
RF CSA as assessed by MSKUS will be measured at hospital discharge.
RF mT at discharge
Time frame: 1 month
RF mT as assessed by MSKUS will be measured at hospital discharge.
RF EI at discharge
Time frame: 1 month
RF EI as assessed by MSKUS will be measured at hospital discharge.
RF CSA at post-discharge outpatient visit
Time frame: 1-3 months
RF CSA as assessed by MSKUS will be measured at outpatient follow-up visit.
RF mT at post-discharge outpatient visit
Time frame: 1-3 months
RF mT as assessed by MSKUS will be measured at outpatient follow-up visit.
RF EI at post-discharge outpatient visit
Time frame: 1-3 months
RF mT as assessed by MSKUS will be measured at outpatient follow-up visit.
ICU Stage: ICU Mobility Scale
Time frame: 7 days
The ICU Mobility Scale is an 11-point scale ranging from 0-10 which involves scoring a patient's maximum level of mobility in the prior 24-hour period. The ICU Mobility Scale will be performed at the same 3 time points as the MSKUS assessments.
Muscle Strength - Medical Research Council Sum-score (MRC-ss) at discharge
Time frame: 1 month
MRC-ss is a measure of global peripheral muscle strength that is the current clinical standard for diagnosing ICU-acquired weakness. Muscle strength is assessed by physical exam and rated on an ordinal scale (0-5) at six bilateral muscle groups: shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors.
Muscle Strength - MRC-ss at post-discharge outpatient visit
Time frame: 1-3 months
MRC-ss is a measure of global peripheral muscle strength that is the current clinical standard for diagnosing ICU-acquired weakness. Muscle strength is assessed by physical exam and rated on an ordinal scale (0-5) at six bilateral muscle groups: shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors.
Muscle Strength - knee extension by hand-held dynamometry (HHD) at hospital discharge
Time frame: 1 month
Maximal isometric knee extensor muscle strength as measured by HHD.
Muscle Strength - knee extension by HHD at post-discharge outpatient visit
Time frame: 1-3 months
Maximal isometric knee extensor muscle strength as measured by HHD.
Muscle Strength - Grip Strength at hospital discharge
Time frame: 1 month
Maximal isometric grip strength as measured by hand-grip dynamometry (HGD)
Muscle Strength - Grip Strength at post-discharge outpatient visit
Time frame: 1-3 months
Maximal isometric grip strength as measured by HGD
Physical Function - Short Physical Performance Battery (SPPB) at discharge
Time frame: 1 month
SPPB is a performance-based composite test with a total of 12 points including components of balance (side-by-side stand, semi-tandem stand, and full-tandem stand), chair-to-stand test, and 4-meter habitual gait speed used to assess physical function and physical frailty.
Physical Function - SPPB at post-discharge outpatient visit
Time frame: 1-3 months
SPPB is a performance-based composite test with a total of 12 points including components of balance (side-by-side stand, semi-tandem stand, and full-tandem stand), chair-to-stand test, and 4-meter habitual gait speed used to assess physical function and physical frailty.
TUG Test at post-discharge outpatient visit
Time frame: 1-3 months
The Timed Up and Go (TUG) test assesses the time (in seconds) for a subject to stand on command from a seated position, walk 3 meters, turn around, walk back to the chair, and sit down, thereby assessing mobility, physical function, and fall risk.
Physical Function - 6-minute walk test (6MWT) at post-discharge outpatient visit
Time frame: 1-3 months
The 6MWT assesses the distance a subject can walk in six minutes, providing a global representation of physical function and cardiopulmonary endurance.
Quality of Life testing using EuroQol Group 5-dimension 5-level (EQ-5D-5L) questionnaire at post-discharge outpatient visit
Time frame: 1-3 months
The EQ-5D-5L is a standardized measure of health status developed by the Euro-Qol Group to provide an assessment of health for clinical and economic appraisal.
Physical Function - Clinical Frailty Scale (CFS) at post-discharge outpatient visit
Time frame: 1-3 months
CFS is a widely adopted judgement-based tool to screen for frailty and to broadly stratify degrees of fitness and frailty.
Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Questionnaire at post-discharge outpatient visit
Time frame: 1-3 months
The FACIT-F scale is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function.
36-Item Short Form Health Survey Physical Function Scale (SF-36) at post-discharge outpatient visit
Time frame: 1-3 months
The SF-36 is a 36-item patient-reported survey of health commonly used to evaluate adult patients which contains 8 domains, including a physical function scale based on 10 of the 36 items which has been shown to have high reliability.
Return to driving
Time frame: 1-3 months
Yes / No outcome assessed at the outpatient follow-up visit
Return to work or hobby
Time frame: 1-3 months
Yes / No outcome assessed at the outpatient follow-up visit
Hospital Readmission
Time frame: 1-3 months
Yes / No outcome assessed at the outpatient follow-up visit
Emergency Department Visit
Time frame: 1-3 months
Yes / No outcome assessed at the outpatient follow-up visit
2 secondary outcomes
ICU Stage: Changes in Plasma Metabolome
Time frame: 7 days
ICU Stage: Changes in CRRT Effluent Metabolome
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background: PubMed 36332719Teixeira 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.
- Background: PubMed 33148301Mayer 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.
- Background: PubMed 33189316Mayer 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.
- Background: PubMed 32302406Mayer 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.
- Background: PubMed 35392844Mayer 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.
- Derived from this study: PubMed 40513259Mayer 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.
- Derived from this study: PubMed 40069097Gonzalez-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.
- Derived from this study: PubMed 37217272Teixeira 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.
- Individual participant dataSharing planned: Undecided
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Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Critical Illness Myopathy, run by University of Iowa at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Stage: rectus femoris (RF) cross-sectional area (CSA) (time frame: 7 days). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05287204, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.