A Study Looking at the Use of Biomarkers to Provide Early Indication of Acute Kidney Injury in Patients With Sepsis (Limiting AKI Progression In Sepsis)

Inclusion Criteria: * Clinical diagnosis of sepsis or septic shock. * Admission to the ICU or planned admission to the ICU with an expected stay of 72 hours or more after enrollment in the same hospital. * Expected to have indwelling urinary catheter placed and kept until at least 48 hours after enrollment. * Written informed consent. Exclusion Criteria: * Women with known pregnancy, prisoners or institutionalized individuals. * Previous renal transplant. * Stage 2 or 3 Acute Kidney Injury (AKI) at screening. * Receiving dialysis (either acute or chronic), or in imminent need of dialysis at enrollment. * Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m2. * Known End Stage Renal Disease (ESRD) or history of active nephrotic syndrome within the last 3 months. * Known Stage 2-3 AKI within last 2 weeks. * Terminally ill (defined as expectation of death within 6 months), has a do not resuscitate order that would restrict protocol-required procedures, or is being admitted only for palliative care. * History of solid organ transplant and receiving calcineurin inhibitors. * Documented serious allergy (i.e. anaphylaxis) to vancomycin, aminoglycosides, penicillins, or cephalosporins (intravenous or oral). * Known current serum total bilirubin \> 4mg/dL. * Subjects already included in an observational study can be co-enrolled in LAPIS. Subjects already included in an interventional study may be enrolled with pre-approval of the sponsor according to the following rules: 1. Co-enrollment in LAPIS will not be allowed with investigational drug and device studies; 2. Studies may be allowed if AKI or kidney function is not an endpoint with pre-approval of the LAPIS sponsor; 3. Co-enrollment in LAPIS will not be allowed if co-enrollment is an exclusion criterion in the other study. * Subjects with laboratory confirmed COVID-19 infection as the primary reason for hospital admission. Other protocol-defined inclusion/exclusion criteria may apply.