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)

  • End date
    Jun 1, 2023
  • participants needed
  • sponsor
Updated on 1 August 2021
septic shock


Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI. Two urinary biomarkers have been identified as early indicators of AKI. The NephroCheck test is a commercially available test that uses these biomarkers, and this study assesses the use of these in reducing negative clinical outcomes for patients with sepsis-associated AKI. The study will enroll subjects diagnosed with sepsis, including septic shock, who will be randomly assigned to either receive NephroCheck-guided kidney-sparing and fast-tracking interventions; or to receive current Standard of Care assessment and treatment.

Condition Renal Failure, Acute renal failure, Septicemia, Toxic Shock Syndrome, Sepsis and Septicemia, Kidney Failure (Pediatric), Kidney Failure, septic shock, systemic infection, systemic infections, acute kidney injury, acute kidney injuries, sepsis, sepsis syndrome
Treatment Standard of Care, NephroCheck®, Subject management guided by NephroCheck® test
Clinical Study IdentifierNCT04434209
Last Modified on1 August 2021


Yes No Not Sure

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
Co-enrollment in LAPIS will not be allowed with investigational drug and device studies
Studies may be allowed if AKI or kidney function is not an endpoint with pre-approval of the LAPIS sponsor
Co-enrollment in LAPIS will not be allowed if co-enrollment is an exclusion criterion in the other study
Other protocol-defined inclusion/exclusion criteria may apply
Subjects with laboratory confirmed COVID-19 infection as the primary reason for hospital admission
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