An interventional study of Implementation of the KDIGO bundle) in Acute Kidney Injury (Nontraumatic), sponsored by University Hospital Muenster. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by University Hospital Muenster · Not applicable, Interventional, and Supportive care
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.
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)
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's planned enrollment of 480 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →University Hospital Muenster is the lead sponsor of 189 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Implementation of the KDIGO bundle)
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%
Comprehensive Implementation of the Bundle recommended by the "Kidney Disease: Improving Global Outcomes Group "(KDIGO bundle)
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
Time frame: 72 hours after start of intervention
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
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
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Plan to share: No
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University Hospital Muenster