Acute Kidney Injury, Sepsis, Septic Shock
Conditions
Keywords
Sepsis, Acute Kidney Injury, Kidney damage, Septic shock, Biomarkers
Brief summary
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. NOTE: Participants are no longer being recruited to this study.
Interventions
DEVICESubject management guided by NephroCheck® test
NephroCheck® is a device using biomarkers to identify subjects at risk of sepsis-associated acute kidney injury
OTHERStandard of Care
Standard of Care patient management
Sponsors
BioMérieux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of deaths, dialysis or progression of AKI | Enrollment to 72 hours | Measured by composite number of deaths, dialysis or progression of AKI. Dialysis defined as any form of renal replacement therapy (RRT); progression of AKI defined as Stage 0 to 2/3 or Stage 1 to 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with progression of AKI | Enrollment to 48 and 72 hours | Progression of AKI (Acute Kidney Injury) to Stage 2 or 3 during the time frame. Measured independently. |
| Number of deaths | Enrollment to 48 and 72 hours | Number of deaths. Measured independently. |
| Number of participants receiving dialysis | Enrollment to 48 and 72 hours | Dialysis defined as any form of renal replacement therapy (RRT). Measured independently. |
| Number participants at Stage 2 or 3 AKI | Enrollment to 72 hours | Defined as highest stage of AKI during the time frame |
| ICU length of stay | Enrollment to hospital discharge or Day 60, whichever is sooner | — |
Countries
Belgium, France, Germany, United States
Contacts
PRINCIPAL_INVESTIGATORHernando Gomez, MD, MPH
Center for Critical Care Nephrology, University of Pittsburgh Medical Center
Outcome results
None listed