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)

NCT04434209 | Terminated DMC FDA Device

• 1 other identifier: LAPIS
• Study Type: interventional
• Target: 19
• Locations: 4 countries
• Sites: 12

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

Keywords

Sepsis; Acute Kidney Injury; Kidney damage; Septic shock; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Number of deaths, dialysis or progression of AKI

  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.

  Enrollment to 72 hours

Secondary Outcomes (5)

• Number of participants with progression of AKI

  Enrollment to 48 and 72 hours

• Number of deaths

  Enrollment to 48 and 72 hours

• Number of participants receiving dialysis

  Enrollment to 48 and 72 hours

• Number participants at Stage 2 or 3 AKI

  Enrollment to 72 hours

• ICU length of stay

  Enrollment to hospital discharge or Day 60, whichever is sooner

Study Arms (2)

NephroCheck-guided interventions

EXPERIMENTAL

Device: Subject management guided by NephroCheck® test

Standard of Care

ACTIVE COMPARATOR

Standard of Care assessment and treatment

Other: Standard of Care

Interventions

Subject management guided by NephroCheck® test DEVICE

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

NephroCheck-guided interventions

Standard of Care OTHER

Standard of Care patient management

Standard of Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Subjects with laboratory confirmed COVID-19 infection as the primary reason for hospital admission.

Sponsors & Collaborators

• BioMérieux: lead

Study Sites (12)

LSU Health Sciences Center, 1541 Kings Highway

Shreveport, Louisiana, 71130, United States

Location

Brigham and Womens Hospital, 75 Francis Street

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan Kettering Cancer Center, 1275 York Avenue

New York, New York, 10065, United States

Location

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

Bruges, West-Vlaanderen, 8000, Belgium

Location

Hôpital Erasme, Soins Intensifs, Route de Lennik 808

Brussels, 1070, Belgium

Location

CHU Angers, 4 Rue Larrey

Angers, Maine-et-Loire, 49100, France

Location

Centre Hospitalier de Béthune, Service de Réanimation et Surveillance continue, 27 rue Delbecque

Béthune, Pas-de-Calais, 62408, France

Location

CHRU Dijon Complexe Du Bocage, Department Infectiologie, 14 rue Gaffarel

Dijon, 21079, France

Location

Hopital Cochin, 27 Rue Du Faubourg Saint Jacques

Paris, 75679, France

Location

University Clinic Heidelberg, Klinik für Anaesthesiologie, Im Neuenheimer Feld 110

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

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

Leipzig, Saxony, 04103, Germany

Location

Universitatsklinikum Munster, Albert-Schweitzer-Campus 1

Münster, 48149, Germany

Location

Related Publications (1)

• 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.

  PMID: 33927121 DERIVED

MeSH Terms

Conditions

Sepsis; Acute Kidney Injury; Shock, Septic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Shock

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Hernando Gomez, MD, MPH

  Center for Critical Care Nephrology, University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 16, 2020
• Study Start: January 19, 2021
• Primary Completion: February 14, 2022
• Study Completion: February 14, 2022
• Last Updated: March 6, 2026

Record last verified: 2025-02

Locations

US (3); BE (2); FR (4); DE (3)