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)

Not Applicable

Terminated

• Conditions: Sepsis; Septic Shock; Acute Kidney Injury
• Interventions: Device: Subject management guided by NephroCheck® test; Other: Standard of Care

• Registration Number: NCT04434209
• Lead Sponsor: BioMérieux

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Study Start: 2021-01-19
• Primary Completion: 2022-02-14
• Study Completion: 2022-02-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NephroCheck-guided interventions	Subject management guided by NephroCheck® test	-
Standard of Care	Standard of Care	Standard of Care assessment and treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 participants receiving dialysis	Enrollment to 48 and 72 hours	Dialysis defined as any form of renal replacement therapy (RRT). Measured independently.
Number of deaths	Enrollment to 48 and 72 hours	Number of deaths. 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

Trial Locations

Locations (12)

LSU Health Sciences Center, 1541 Kings Highway; 🇺🇸 Shreveport, Louisiana, United States

Brigham and Womens Hospital, 75 Francis Street; 🇺🇸 Boston, Massachusetts, United States

Hôpital Erasme, Soins Intensifs, Route de Lennik 808; 🇧🇪 Bruxelles, Belgium

CHU Angers, 4 Rue Larrey; 🇫🇷 Angers, Maine-et-Loire, France

Centre Hospitalier de Béthune, Service de Réanimation et Surveillance continue, 27 rue Delbecque; 🇫🇷 Béthune, Pas-de-Calais, France

AZ Sint-Jan Brugge-Oostende, Intensieve Zorgen, Ruddershove 10; 🇧🇪 Brugge, West-Vlaanderen, Belgium

Memorial Sloan Kettering Cancer Center, 1275 York Avenue; 🇺🇸 New York, New York, United States

CHRU Dijon Complexe Du Bocage, Department Infectiologie, 14 rue Gaffarel; 🇫🇷 Dijon, France

Hopital Cochin, 27 Rue Du Faubourg Saint Jacques; 🇫🇷 Paris, France

University Clinic Heidelberg, Klinik für Anaesthesiologie, Im Neuenheimer Feld 110; 🇩🇪 Heidelberg, Baden-Württemberg, Germany

Universitatsklinikum Munster, Albert-Schweitzer-Campus 1; 🇩🇪 Münster, Germany

Universitatsklinikum Leipzig, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Liebigstraße 20; 🇩🇪 Leipzig, Sachsen, Germany