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

NCT07746063 | Completed

• 1 other identifier: B3 D2 AKI - Study
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

AKI detection system

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants Surviving at 90 Days

  Defined as alive at 90 days post-inclusion. Assessed via telephone follow-up and medical record review.

  90 days after study inclusion

• Proportion of Participants Surviving at 365 Days

  Defined as alive at 365 days post-inclusion. Assessed via telephone follow-up and medical record review.

  365 days after study inclusion

Secondary Outcomes (3)

• Proportion of Participants Aware of AKI Diagnosis

  90 days after study inclusion

• Perceived Severity of AKI (Likert Scale)

  90 days after study inclusion

• Proportion of Participants with Follow-Up Kidney Function Testing within 90 Days

  90 days after study inclusion

Study Arms (1)

AKI Stage 3

Patients (≥18 years) with stage 3 acute kidney injury (AKI) as defined by the following criteria: a ≥3-fold increase in serum creatinine from baseline, a serum creatinine level ≥4 mg/dL with an acute rise of ≥0.5 mg/dL, or oliguria (\<0.5 mL/kg/h for \>6 hours). Patients were identified via the institutional AKI alert system and confirmed by a nephrologist.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In-house patients of the academic teaching hospital Braunschweig

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead
• Academic Teaching Hospital Braunschweig: collaborator

Study Sites (1)

Academic Teaching Hospital Braunschweig

Braunschweig, Germany

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jan T Kielstein, MD

  Academic Teaching Hospital Braunschweig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)