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.
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
Dialysis-dependent chronic kidney disease
Prior kidney transplant
Infections with human immunodeficiency virus or hepatitis
Hepatorenal syndrome
Parallel
Implementation of the KDIGO bundle)
Procedure/SurgeryComprehensive 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
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
Length of intensive care unit stay
Hospital length of stay
Duration of renal replacement therapy
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University Hospital Muenster
Lead sponsor
Baxter Healthcare Corporation
Collaborator
