Body Composition, Kidney Size, and Medication Dosing in Acute Kidney Injury: Follow-Up at 90 Days… (NCT07746063) | Clinical Trial Compass
CompletedNot Applicable
Body Composition, Kidney Size, and Medication Dosing in Acute Kidney Injury: Follow-Up at 90 Days and 12 Months
Germany154 participantsStarted 2021-08-01
Plain-language summary
Acute Kidney Injury (AKI) is a common and serious condition affecting up to 12% of hospitalized patients, with increasing severity linked to higher mortality. Despite early detection via automated warning systems, clinical outcomes such as hospital length of stay, dialysis need, and death remain suboptimal. This non-interventional study evaluates modifiable factors influencing AKI outcomes by integrating four key components: body composition, kidney size, medication dosing, and patient-reported outcomes. Body composition is assessed using non-invasive bioimpedance spectroscopy to evaluate fluid status, muscle mass, and fat mass. Kidney size and structure are assessed via point-of-care ultrasound to detect underlying chronic kidney disease or obstructive causes. A standardized national medication plan is used to review drug dosing, interactions, and potential errors, supported by nephrology and pharmacy expertise. Additionally, patients are contacted by telephone at 90 and 365 days post-diagnosis to assess awareness of AKI, perceived severity, health literacy, and current kidney function (via blood tests and medication review). The study evaluates whether early, multidimensional assessment is associated with improved patient understanding, care coordination, and long-term outcomes. Findings may inform future strategies to enhance AKI management, reduce complications, and improve patient-centered care.
Who can participate
Age range
18 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:
* Age: Adult patients (≥18 years)
* Diagnosis: Confirmed diagnosis of Acute Kidney Injury (AKI) Stage 3, defined by one of the following: Increase in serum creatinine ≥3-fold from baseline, Serum creatinine ≥4 mg/dL with an acute rise of ≥0.5 mg/dL, Oliguria (\<0.5 mL/kg/h for \>6 hours)
* Informed Consent: Willingness to provide written informed consent for participation in the study
Exclusion Criteria:
* Participation in another clinical trial: Participation in any other interventional or observational clinical study within the last 4 weeks prior to study enrollment
* Short life expectancy: Clinically assessed life expectancy of less than 28 days by the treating physician
* Inability to consent: Cognitive or language barriers that prevent informed consent or participation in telephone follow-up
* Terminal illness: Active, untreated, or progressive terminal illness (e.g., advanced cancer with no curative intent)
* Inability to follow up: Unavailability of contact information or inability to be reached by telephone at 90 and 365 days post-discharge
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.
1Since this trial has already been completed, would my doctor be able to share or access any of the findings about how body composition and kidney size affected survival outcomes at 90 days and 12 months — and could those findings change how my own acute kidney injury is being managed?
2This study looked at how body composition affects medication dosing in acute kidney injury — should I be asking whether my current medication doses have been adjusted based on my body size or kidney measurements, and is that something my care team is actively monitoring?
3Because this was an observational follow-up study rather than a treatment trial, it didn't test a new therapy — so what standard treatment options exist for acute kidney injury that my doctor recommends I consider right now, rather than waiting for research like this to translate into new protocols?
4The trial tracked survival at both 90 days and 365 days — given my specific situation, what does my doctor estimate my own recovery trajectory looks like at those same timepoints, and what factors most influence that for someone with my type of acute kidney injury?
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.