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Body Composition, Kidney Size, and Medication Dosing in Acute Kidney Injury: Follow-Up at 90 Days and 12 Months

Body Composition, Kidney Size, and Medication Dosing in Patients With Acute Kidney Injury: A Telephone-Based Follow-Up Study at 90 Days and 12 Months

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07746063
Enrollment
154
Registered
2026-08-04
Start date
2021-08-01
Completion date
2022-09-01
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

AKI detection system

Brief 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.

Detailed description

Acute kidney injury (AKI) is a common and serious condition affecting up to 12% of hospitalized patients, with mortality increasing significantly with severity. Despite the implementation of automated AKI alert systems, clinical outcomes such as hospital length of stay, dialysis need, and death remain suboptimal. This non-interventional, single-center study aims to improve understanding of modifiable factors influencing AKI outcomes by integrating four key components: body composition, kidney size, medication dosing, and patient-reported outcomes. The primary objective is to assess the prevalence of fluid imbalance, structural kidney abnormalities, and medication errors in patients with AKI Stage 3. It is hypothesized that most patients with AKI are not in a state of euvolemia (i.e., they have either fluid overload or dehydration), that pre-existing chronic kidney disease is detectable via abnormal kidney sonography, and that a significant proportion of patients have medication dosing errors, including inappropriate, contraindicated, or nephrotoxic drugs. Secondary objectives include evaluating patient awareness of AKI diagnosis, assessing whether patients receive follow-up kidney function monitoring within 90 days after hospital discharge, and identifying gaps in post-discharge care. It is hypothesized that fewer than 100% of patients are aware of their AKI diagnosis, and that a substantial proportion do not undergo follow-up kidney function testing within 90 days. The study population includes adult patients (≥18 years) with a confirmed diagnosis of AKI Stage 3, defined by an increase in serum creatinine ≥3-fold from baseline or ≥4 mg/dL with an acute rise of ≥0.5 mg/dL, or oliguria (\<0.5 mL/kg/h for \>6 hours). Patients are identified via the hospital's automated AKI alert system and approached by the nephrology consultative service during hospitalization. Inclusion requires informed consent; exclusion criteria include participation in another clinical trial within the past 4 weeks or a life expectancy of less than 28 days, as judged by the treating physician. A total of approximately 120 patients are planned for inclusion, with the expectation that around 100 will be available for follow-up at 90 and 365 days post-discharge. Data collection includes electronic health records (Nephro7, SAP) for vital signs, laboratory values, diagnoses, and medication lists. Additional assessments include: * Body composition analysis using non-invasive bioimpedance spectroscopy (50 frequencies, 5-1000 kHz) to measure total body water, extracellular water, muscle mass, and fat mass. Overhydration (\>1000 mL) is a primary outcome. * Point-of-care ultrasound of the kidneys to assess kidney length (\<10 cm), parenchymal thickness (\<10 mm), and signs of chronic kidney disease or obstruction. Findings are correlated with estimated glomerular filtration rate (eGFR \<45 mL/min). * Medication review using the national standardized medication plan (Bundesmedikationsplan), supplemented by a joint evaluation by a nephrologist and clinical pharmacist to identify dosing errors, contraindications, or nephrotoxic drugs. Patients are contacted by telephone at 90 and 365 days after AKI diagnosis to assess: * Awareness of the AKI diagnosis (Yes/No), * Perceived severity of the event (Likert scale: 1-5), * Health literacy regarding AKI (Likert scale: 1-5), * Whether kidney function (serum creatinine, urea, potassium) was rechecked by their primary care provider within 90 days. All data are anonymized and stored securely on hospital servers. The study is non-interventional; no changes to standard care are made. The only interventions are the assessments and follow-up calls. The study is ethically approved and conducted in accordance with GDPR and local regulations. The anticipated benefits include improved patient safety through early detection of fluid imbalance, kidney structural changes, and medication errors. The follow-up calls may prompt overdue kidney function checks by primary care providers. Risks are minimal: potential anxiety from the phone call is mitigated by trained staff and clear communication. The study is considered medically justified as it enhances care quality beyond routine practice. Data collection concludes with the final follow-up call at 365 days post-AKI alert. Results will inform strategies to improve AKI management, patient education, and post-discharge monitoring, ultimately reducing complications and improving long-term outcomes.

Interventions

None listed

Sponsors

Hannover Medical School
Lead SponsorOTHER
Academic Teaching Hospital Braunschweig
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Participants Surviving at 90 Days90 days after study inclusionDefined as alive at 90 days post-inclusion. Assessed via telephone follow-up and medical record review.
Proportion of Participants Surviving at 365 Days365 days after study inclusionDefined as alive at 365 days post-inclusion. Assessed via telephone follow-up and medical record review.

Secondary

MeasureTime frameDescription
Proportion of Participants Aware of AKI Diagnosis90 days after study inclusionAssessed via structured telephone interview: "Do you know you had acute kidney injury during your hospital stay?" (Yes/No).
Perceived Severity of AKI (Likert Scale)90 days after study inclusionAssessed using a 5-point Likert scale: 1 = not severe, 2 = slightly severe, 3 = moderately severe, 4 = severely severe, 5 = very severely severe.
Proportion of Participants with Follow-Up Kidney Function Testing within 90 Days90 days after study inclusionDefined as serum creatinine, urea, and potassium measured by the primary care provider within 90 days of study inclusion. Confirmed via patient report and primary care medical record review.

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORJan T Kielstein, MD

Academic Teaching Hospital Braunschweig

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026