UnknownNot Applicable

Critical Illness Myopathy and Trajectory of Recovery in AKI Requiring CRRT

United States10 participantsStarted 2021-11-29

Plain-language 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.

Who can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ICU Stage: rectus femoris (RF) cross-sectional area (CSA)

Timeframe: 7 days

ICU Stage: RF muscle thickness (mT)

Timeframe: 7 days

ICU Stage: RF echo intensity (EI)

Timeframe: 7 days

RF CSA at discharge

Timeframe: 1 month

RF mT at discharge

Timeframe: 1 month

RF EI at discharge

Timeframe: 1 month

RF CSA at post-discharge outpatient visit

Timeframe: 1-3 months

RF mT at post-discharge outpatient visit

Timeframe: 1-3 months

Trial details

NCT IDNCT05287204

SponsorUniversity of Iowa

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-30

View on ClinicalTrials.gov More Acute Kidney Injury trials

Who can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

ICU Stage: rectus femoris (RF) cross-sectional area (CSA)

Timeframe: 7 days

ICU Stage: RF muscle thickness (mT)

Timeframe: 7 days

ICU Stage: RF echo intensity (EI)

Timeframe: 7 days

RF CSA at discharge

Timeframe: 1 month

RF mT at discharge

Timeframe: 1 month

RF EI at discharge

Timeframe: 1 month

RF CSA at post-discharge outpatient visit

Timeframe: 1-3 months

RF mT at post-discharge outpatient visit

Timeframe: 1-3 months