Effect of an Intervention to Prevent Acute Kidney Injury Versus Standard Care in High-risk Patients After Major Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Implementation of the KDIGO bundle): Comprehensive Implementation of the Bundle recommended by the "Kidney Disease: Improving Global Outcomes Group "(KDIGO bundle)

Study 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 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.

Eligibility

Primary outcome measure(s)

• Occurrence of persistent severe AKI — 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

Trial sites (1)

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