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)

NCT ID: NCT04434209

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-19
• Study Completion Date: 2022-02-14

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.

Conditions

Sepsis; Acute Kidney Injury; Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

NephroCheck-guided interventions

Group Type: EXPERIMENTAL

Subject management guided by NephroCheck® test

Intervention Type: DEVICE

NephroCheck® is a device using biomarkers to identify subjects at risk of sepsis-associated acute kidney injury

Standard of Care

Standard of Care assessment and treatment

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Standard of Care patient management

Interventions

Subject management guided by NephroCheck® test

NephroCheck® is a device using biomarkers to identify subjects at risk of sepsis-associated acute kidney injury

Intervention Type: DEVICE

Standard of Care

Standard of Care patient management

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioMérieux

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hernando Gomez, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Center for Critical Care Nephrology, University of Pittsburgh Medical Center

Locations

LSU Health Sciences Center, 1541 Kings Highway

Shreveport, Louisiana, United States

Brigham and Womens Hospital, 75 Francis Street

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center, 1275 York Avenue

New York, New York, United States

AZ Sint-Jan Brugge-Oostende, Intensieve Zorgen, Ruddershove 10

Bruges, West-Vlaanderen, Belgium

Hôpital Erasme, Soins Intensifs, Route de Lennik 808

Brussels, , 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

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-Wurttemberg, Germany

Universitatsklinikum Leipzig, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Liebigstraße 20

Leipzig, Saxony, Germany

Universitatsklinikum Munster, Albert-Schweitzer-Campus 1

Münster, , Germany

Countries

United States; Belgium; France; Germany

References

Molinari L, Heskia F, Peerapornratana S, Ronco C, Guzzi L, Toback S, Birch R, Beyhaghi H, Kwan T, Kampf JP, Yealy DM, Kellum JA; Sapphire and Protocolized Care for Early Septic Shock (ProCESS) Investigators. Limiting Acute Kidney Injury Progression In Sepsis: Study Protocol and Trial Simulation. Crit Care Med. 2021 Oct 1;49(10):1706-1716. doi: 10.1097/CCM.0000000000005061.

Reference Type: DERIVED

PMID: 33927121 (View on PubMed)

Other Identifiers

LAPIS

Identifier Type: -

Identifier Source: org_study_id