Status:
TERMINATED
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)
Lead Sponsor:
BioMérieux
Conditions:
Sepsis
Acute Kidney Injury
Eligibility:
All Genders
21+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
- Subjects with laboratory confirmed COVID-19 infection as the primary reason for hospital admission.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
January 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04434209
Start Date
January 19 2021
End Date
February 14 2022
Last Update
February 20 2025
Active Locations (12)
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1
LSU Health Sciences Center, 1541 Kings Highway
Shreveport, Louisiana, United States, 71130
2
Brigham and Womens Hospital, 75 Francis Street
Boston, Massachusetts, United States, 02115
3
Memorial Sloan Kettering Cancer Center, 1275 York Avenue
New York, New York, United States, 10065
4
AZ Sint-Jan Brugge-Oostende, Intensieve Zorgen, Ruddershove 10
Bruges, West-Vlaanderen, Belgium, 8000