Acute Kidney Injury (Nontraumatic)PrevProgAKINCT05275218
Effect of an Intervention to Prevent Acute Kidney Injury Versus Standard Care in High-risk Patients After Major Surgery
A study testing Implementation of the KDIGO bundle) in people with Acute Kidney Injury (Nontraumatic), run by University Hospital Muenster at 1 site in Germany.
Trial summary
There is no specific therapy for acute kidney injury. It is presumed that supportive measures improve the care and outcome of patients with acute kidney injury. To investigate whether an implementation of a supportive extended care "bundle" in high-risk patients for persistent acute kidney injury (AKI) can reduce the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury (Nontraumatic)
- What is being tested?
- Implementation of the KDIGO bundle)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteGermany
- Study dates
- 22 Mar 2023to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adult patients (age ≥18 years)
- Moderate or severe AKI ((defined by the 2012 KDIGO criteria, KDIGO stage 2 and 3), determined by either serum creatinine or urine output) within 72h after a surgical procedure
- Written informed consent
Who cannot join
- Dialysis-dependent chronic kidney disease
- Prior kidney transplant
- Infections with human immunodeficiency virus or hepatitis
- Hepatorenal syndrome
- Pregnancy or breast-feeding
- Participation in another interventional trial that investigates a drug that affects the kidney function within the last 3 months
- Persons held in an institution by legal or official order
- Persons with any kind of dependency on the investigator or employed by the responsible institution or investigator
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Münster; 1Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
Münster
About this study
Official title: Effect of an Extended "Kidney Disease: Improving Global Outcomes" (KDIGO) Bundle Versus Standard of Care Therapy on Persistent Acute Kidney Injury in High-risk Patients After Major Surgery
There is no specific therapy for acute kidney injury. It is presumed that supportive measures improve the care and outcome of patients with acute kidney injury.
To investigate whether an implementation of a supportive extended care "bundle" in high-risk patients for persistent acute kidney injury (AKI) can reduce the occurrence of persistent surgical AKI.
In order to investigate whether the extended KDIGO bundle can prevent persistent AKI in patients with high chemokine ligand 14 (CCL14) as well as in patients with low CCL14, patients will be randomized with stratification by the CCL-value.
Read the detailed description
All patients will receive standard of care therapy according to the standards of our center. After identifying surgical patients with a moderate or severe (stage 2 or 3) AKI patients will be randomly allocated to the control or intervention group according to the CCL14 results which will be measured as part of the study. According to the literature, patients with a CCL14 <1.3ng/ml are at low risk of progression and patients with a CCL14≥1.3ng/ml are at high risk of AKI progression. In order to have both patient groups included, we will have two groups (patients at low and at high risk of AKI progression) and these will be randomized to receive either standard of care or an extended KDIGO bundle (in total 4 groups).
Control intervention / reference test: Patients in the control groups will be treated according to the standard of care. The only two hemodynamic targets in this group are the mean arterial pressure (mean arterial pressure (MAP)>65mmHg) and passive leg raising test (PLRT) (increase of cardiac output (CO) <10%).
In the intervention groups, an extended KDIGO guideline bundle will be implemented (Discontinuation of all nephrotoxic agents when possible, optimization of volume status and perfusion pressure, consideration of a functional hemodynamic monitoring, close monitoring of serum creatinine and urine output, avoidance of hyperglycemia, consideration of alternatives to radio contrast agents, non-invasive or invasive diagnostic workup, nephrology consultation)
- Conditions
- Acute Kidney Injury (Nontraumatic)
- Being tested
- Implementation of the KDIGO bundle)
- Keywords
- surgery, biomarker, CCL14 protein
- 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.
Implementation of the KDIGO bundle)Procedure or surgery
Comprehensive Implementation of the Bundle recommended by the "Kidney Disease: Improving Global Outcomes Group "(KDIGO bundle)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Implementation of the KDIGO bundle for at least 72 hours 1. Discontinuation of all nephrotoxic drugs when possible 2. Optimization of volume status and perfusion pressure. 3. Consideration of a functional hemodynamic monitoring. 4.Close monitoring of serum creatinine, and urinary output 5. Avoidance of hyperglycemia 6. Considerations of alternatives to radiocontrast agents 7. Non-invasive or invasive diagnostic workup 8. Nephrology consultation. Receives: Procedure: Implementation of the KDIGO bundle) |
| Control Group | No intervention | Patients in the control group will receive standard of care. According to best clinical practice, this includes the following targets (unless specific individual targets are chosen by treating physician): * mean arterial pressure (MAP): ≥ 65 mmHg * passive leg raising test (PLRT): increase of cardiac output (CO)<10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of persistent severe AKI
The primary endpoint is the development of persistent severe (stage 3) AKI lasting for at least 72h defined as ≥3-fold increase in serum creatinine in relation to baseline or serum creatinine ≥4.0mg/dl with an acute increase of 0.5mg/dl or a decrease in urine output <0.3ml/kg/h for 24 hours or anuria for 12 hours. Persistent AKI is defined as follows: patients with stage 3 AKI at enrollment require a persistence of 72h or more to meet the endpoint. Patients enrolled at stage 2 AKI require a progression to stage 3 within 48 hours and a persistence at stage 3 for 72 consecutive hours to be considered endpoint positive. Additionally, patients with severe AKI who fail to achieve 72h due to death or the initiation of renal replacement therapy are considered endpoint positive as well
Measured: 72 hours after start of intervention
Secondary outcomes (20)
Number of patients with major adverse kidney events (MAKE)
Composite endpoint consisting of death or initiation of renal replacement therapy within 90 days or persistent renal dysfunction (defined as a decrease in estimated glomerular filtration rate (eGFR) to < 75% of baseline)
- The baseline serum creatinine is taken as the value obtained prior to the day of operation
Measured: 90 days after start of intervention
Length of intensive care unit stay
Measured: up to 90 days after start of intervention
Hospital length of stay
Measured: up to 90 days after start of intervention
Duration of renal replacement therapy
Measured: up to 28 days
Rate of renal replacement therapy
Measured: up to 28 days
Fluid balance
Measured: during intensive care unit stay
Dose of vasopressors
Measured: during intensive care unit stay
Duration of vasopressors
Measured: during hospital stay (up to 90 days after start of intervention)
Rate of infection during intensive care unit stay
Measured: during intensive care unit stay (up to 28 days after start of intervention)
Sequential organ failure assessment (SOFA) score
Measured: daily at days 1 to 14 after start of intervention
Sequential organ failure assessment (SOFA) score
Measured: daily at day 1 to 14, day 21 and day 28
Sequential organ failure assessment (SOFA) score
Measured: daily at days 28 after start of intervention
Need of renal replacement therapy (RRT)
Measured: 28 days after start of intervention
Need of renal replacement therapy (RRT)
Measured: 60 days after start of intervention
Need of renal replacement therapy (RRT)
Measured: 90 days after start of intervention
Need of renal replacement therapy (RRT)
Measured: 365 days after start of intervention
Rate of mortality
Measured: 90 days after start of intervention
Rate of mortality
Measured: 365 days after start of intervention
Rate of persistent renal dysfunction
Measured: 90 days after start of intervention
Rate of persistent renal dysfunction
Measured: 365 days after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start22 Mar 2023
- Primary completion9 Feb 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney Injury (Nontraumatic)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Zarbock, MD, Study chair, University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275218
- Sponsor's protocol ID
- 08-AnIt-21
- Acronym
- PrevProgAKI
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sadjadi M, Strauss C, von Groote T, Booke H, Schone LM, Sauermann L, Wempe C, Gerss J, Kellum J, Meersch M, Zarbock A. Effects of an extended therapeutic strategy versus standard-of-care therapy on persistent acute kidney injury in high-risk patients after major surgery: study protocol for the randomised controlled single-centre PrevProgAKI trial. BMJ Open. 2025 May 6;15(5):e097333. doi: 10.1136/bmjopen-2024-097333.
PubMed 40328648
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Extended "Kidney Disease: Improving Global Outcomes" (KDIGO) Bundle Versus Standard of Care Therapy on Persistent Acute Kidney Injury in High-risk Patients After Major Surgery
- ClinicalTrials.gov ID
- NCT05275218
- Acronym / sponsor ID
- PrevProgAKI / 08-AnIt-21
- Conditions
- Acute Kidney Injury (Nontraumatic)
- Keywords
- surgery, biomarker, CCL14 protein
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 11 Mar 2022 (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.
There is no specific therapy for acute kidney injury. It is presumed that supportive measures improve the care and outcome of patients with acute kidney injury.
To investigate whether an implementation of a supportive extended care "bundle" in high-risk patients for persistent acute kidney injury (AKI) can reduce the occurrence of persistent surgical AKI.
In order to investigate whether the extended KDIGO bundle can prevent persistent AKI in patients with high chemokine ligand 14 (CCL14) as well as in patients with low CCL14, patients will be randomized with stratification by the CCL-value.
Detailed description
All patients will receive standard of care therapy according to the standards of our center. After identifying surgical patients with a moderate or severe (stage 2 or 3) AKI patients will be randomly allocated to the control or intervention group according to the CCL14 results which will be measured as part of the study. According to the literature, patients with a CCL14 <1.3ng/ml are at low risk of progression and patients with a CCL14≥1.3ng/ml are at high risk of AKI progression. In order to have both patient groups included, we will have two groups (patients at low and at high risk of AKI progression) and these will be randomized to receive either standard of care or an extended KDIGO bundle (in total 4 groups).
Control intervention / reference test: Patients in the control groups will be treated according to the standard of care. The only two hemodynamic targets in this group are the mean arterial pressure (mean arterial pressure (MAP)>65mmHg) and passive leg raising test (PLRT) (increase of cardiac output (CO) <10%).
In the intervention groups, an extended KDIGO guideline bundle will be implemented (Discontinuation of all nephrotoxic agents when possible, optimization of volume status and perfusion pressure, consideration of a functional hemodynamic monitoring, close monitoring of serum creatinine and urine output, avoidance of hyperglycemia, consideration of alternatives to radio contrast agents, non-invasive or invasive diagnostic workup, nephrology consultation)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Implementation of the KDIGO bundle)Implementation of the KDIGO bundle for at least 72 hours 1. Discontinuation of all nephrotoxic drugs when possible 2. Optimization of volume status and perfusion pressure. 3. Consideration of a functional hemodynamic monitoring. 4.Close monitoring of serum creatinine, and urinary output 5. Avoidance of hyperglycemia 6. Considerations of alternatives to radiocontrast agents 7. Non-invasive or invasive diagnostic workup 8. Nephrology consultation. |
| Control Group | No intervention | –Patients in the control group will receive standard of care. According to best clinical practice, this includes the following targets (unless specific individual targets are chosen by treating physician): * mean arterial pressure (MAP): ≥ 65 mmHg * passive leg raising test (PLRT): increase of cardiac output (CO)<10% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age ≥18 years)
- Moderate or severe AKI ((defined by the 2012 KDIGO criteria, KDIGO stage 2 and 3), determined by either serum creatinine or urine output) within 72h after a surgical procedure
- Written informed consent
Key exclusion criteria (8 listed)
- Dialysis-dependent chronic kidney disease
- Prior kidney transplant
- Infections with human immunodeficiency virus or hepatitis
- Hepatorenal syndrome
- Pregnancy or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of the KDIGO bundle)Comprehensive Implementation of the Bundle recommended by the "Kidney Disease: Improving Global Outcomes Group "(KDIGO bundle) | Procedure or surgery | Intervention Group |
Primary outcome
Occurrence of persistent severe AKI
Time frame: 72 hours after start of intervention
The primary endpoint is the development of persistent severe (stage 3) AKI lasting for at least 72h defined as ≥3-fold increase in serum creatinine in relation to baseline or serum creatinine ≥4.0mg/dl with an acute increase of 0.5mg/dl or a decrease in urine output <0.3ml/kg/h for 24 hours or anuria for 12 hours. Persistent AKI is defined as follows: patients with stage 3 AKI at enrollment require a persistence of 72h or more to meet the endpoint. Patients enrolled at stage 2 AKI require a progression to stage 3 within 48 hours and a persistence at stage 3 for 72 consecutive hours to be considered endpoint positive. Additionally, patients with severe AKI who fail to achieve 72h due to death or the initiation of renal replacement therapy are considered endpoint positive as well
20 secondary outcomes
Number of patients with major adverse kidney events (MAKE)
Time frame: 90 days after start of intervention
Length of intensive care unit stay
Time frame: up to 90 days after start of intervention
Hospital length of stay
Time frame: up to 90 days after start of intervention
Duration of renal replacement therapy
Time frame: up to 28 days
Rate of renal replacement therapy
Time frame: up to 28 days
Fluid balance
Time frame: during intensive care unit stay
Dose of vasopressors
Time frame: during intensive care unit stay
Duration of vasopressors
Time frame: during hospital stay (up to 90 days after start of intervention)
Rate of infection during intensive care unit stay
Time frame: during intensive care unit stay (up to 28 days after start of intervention)
Sequential organ failure assessment (SOFA) score
Time frame: daily at days 1 to 14 after start of intervention
Sequential organ failure assessment (SOFA) score
Time frame: daily at day 1 to 14, day 21 and day 28
Sequential organ failure assessment (SOFA) score
Time frame: daily at days 28 after start of intervention
Need of renal replacement therapy (RRT)
Time frame: 28 days after start of intervention
Need of renal replacement therapy (RRT)
Time frame: 60 days after start of intervention
Need of renal replacement therapy (RRT)
Time frame: 90 days after start of intervention
Need of renal replacement therapy (RRT)
Time frame: 365 days after start of intervention
Rate of mortality
Time frame: 90 days after start of intervention
Rate of mortality
Time frame: 365 days after start of intervention
Rate of persistent renal dysfunction
Time frame: 90 days after start of intervention
Rate of persistent renal dysfunction
Time frame: 365 days after start of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Derived from this study: PubMed 40328648Sadjadi M, Strauss C, von Groote T, Booke H, Schone LM, Sauermann L, Wempe C, Gerss J, Kellum J, Meersch M, Zarbock A. Effects of an extended therapeutic strategy versus standard-of-care therapy on persistent acute kidney injury in high-risk patients after major surgery: study protocol for the randomised controlled single-centre PrevProgAKI trial. BMJ Open. 2025 May 6;15(5):e097333. doi: 10.1136/bmjopen-2024-097333.
- Individual participant dataSharing planned: No
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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.
Zarbock, MD study chair
University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of the KDIGO bundle) in people with Acute Kidney Injury (Nontraumatic), run by University Hospital Muenster 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 8 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: under way, not looking for participants, as of the sponsor's last update on 21 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?
This study is still under way. Results are not available in the source record yet.
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?
Occurrence of persistent severe AKI (time frame: 72 hours after start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05275218, which also lists 1 linked publication.
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 21 Aug 2026.