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Completed
NCT07746063
Body Composition, Kidney Size, and Medication Dosing in Acute Kidney Injury: Follow-Up at 90 Days and 12 Months
Conditions: Acute Kidney Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 154
Sponsor: Hannover Medical School
Location: Academic Teaching Hospital Braunschweig Braunschweig
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.
Eligibility Criteria
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 (\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
Source: ClinicalTrials.gov (NCT07746063). StuddyBuddy aggregates publicly available trial information.