Acute Kidney InjuryNCT07746063
Body Composition, Kidney Size, and Medication Dosing in Acute Kidney Injury: Follow-Up at 90 Days and 12 Months
An observational study of Acute Kidney Injury, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 154 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In-house patients of the academic teaching hospital Braunschweig
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Keywords
- AKI detection system
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Surviving at 90 Days
Defined as alive at 90 days post-inclusion. Assessed via telephone follow-up and medical record review.
Measured: 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.
Measured: 365 days after study inclusion
Secondary outcomes (3)
Proportion of Participants Aware of AKI Diagnosis
Assessed via structured telephone interview: "Do you know you had acute kidney injury during your hospital stay?" (Yes/No).
Measured: 90 days after study inclusion
Perceived Severity of AKI (Likert Scale)
Assessed using a 5-point Likert scale: 1 = not severe, 2 = slightly severe, 3 = moderately severe, 4 = severely severe, 5 = very severely severe.
Measured: 90 days after study inclusion
Proportion of Participants with Follow-Up Kidney Function Testing within 90 Days
Defined 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.
Measured: 90 days after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Aug 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Teaching Hospital Braunschweig
- Responsible party
- Sponsor
- Investigators
- Jan T Kielstein, MD, Principal investigator, Academic Teaching Hospital Braunschweig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746063
- Sponsor's protocol ID
- B3 D2 AKI - Study
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual-level data (IPD) will not be shared due to ethical and legal constraints. All data collected in this study are anonymized and stored in compliance with the General Data Protection Regulation (GDPR). The study involves sensitive health information, and sharing raw individual data would pose a risk of re-identification, even after anonymization. Furthermore, the study is non-interventional and does not include a data-sharing agreement with external partners. Therefore, IPD will remain confidential and accessible only to the study team at Academic Teaching Hospital Braunschweig. Aggregate results will be published in peer-reviewed journals, but individual-level data will not be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07746063
- Acronym / sponsor ID
- B3 D2 AKI - Study
- Conditions
- Acute Kidney Injury
- Keywords
- AKI detection system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Academic Teaching Hospital Braunschweig
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In-house patients of the academic teaching hospital Braunschweig
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Participants Surviving at 90 Days
Time frame: 90 days after study inclusion
Defined as alive at 90 days post-inclusion. Assessed via telephone follow-up and medical record review.
Proportion of Participants Surviving at 365 Days
Time frame: 365 days after study inclusion
Defined as alive at 365 days post-inclusion. Assessed via telephone follow-up and medical record review.
3 secondary outcomes
Proportion of Participants Aware of AKI Diagnosis
Time frame: 90 days after study inclusion
Perceived Severity of AKI (Likert Scale)
Time frame: 90 days after study inclusion
Proportion of Participants with Follow-Up Kidney Function Testing within 90 Days
Time frame: 90 days after study inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No. Individual-level data (IPD) will not be shared due to ethical and legal constraints. All data collected in this study are anonymized and stored in compliance with the General Data Protection Regulation (GDPR). The study involves sensitive health information, and sharing raw individual data would pose a risk of re-identification, even after anonymization. Furthermore, the study is non-interventional and does not include a data-sharing agreement with external partners. Therefore, IPD will remain confidential and accessible only to the study team at Academic Teaching Hospital Braunschweig. Aggregate results will be published in peer-reviewed journals, but individual-level data will not be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan T Kielstein, MD principal investigator
Academic Teaching Hospital Braunschweig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Surviving at 90 Days (time frame: 90 days after study inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.