LAPIS: 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)

Sponsor

BioMérieux (Industry)

Overall Status

Terminated

CT.gov ID

NCT04434209

Collaborator

(none)

Enrollment

Locations

Arms

12.8

Actual Duration (Months)

1.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Acute Kidney Injury Septic Shock	Device: Subject management guided by NephroCheck® test Other: Standard of Care	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

Limiting AKI Progression In Sepsis (LAPIS): A Phase 4, Multicenter, Randomized Controlled Trial of Biomarker-guided Delivery of Kidney-sparing Care Measures in Sepsis Subjects at Risk of Developing AKI

Actual Study Start Date :

Jan 19, 2021

Actual Primary Completion Date :

Feb 14, 2022

Actual Study Completion Date :

Feb 14, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NephroCheck-guided interventions	Device: Subject management guided by NephroCheck® test NephroCheck® is a device using biomarkers to identify subjects at risk of sepsis-associated acute kidney injury
Active Comparator: Standard of Care Standard of Care assessment and treatment	Other: Standard of Care Standard of Care patient management

Arm

Intervention/Treatment

Experimental: NephroCheck-guided interventions

Device: Subject management guided by NephroCheck® test

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

Active Comparator: Standard of Care

Standard of Care assessment and treatment

Other: Standard of Care

Standard of Care patient management

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	Brugge	West-Vlaanderen	Belgium	8000
5	Hôpital Erasme, Soins Intensifs, Route de Lennik 808	Bruxelles		Belgium	1070
6	CHU Angers, 4 Rue Larrey	Angers	Maine-et-Loire	France	49100
7	Centre Hospitalier de Béthune, Service de Réanimation et Surveillance continue, 27 rue Delbecque	Béthune	Pas-de-Calais	France	62408
8	CHRU Dijon Complexe Du Bocage, Department Infectiologie, 14 rue Gaffarel	Dijon		France	21079
9	Hopital Cochin, 27 Rue Du Faubourg Saint Jacques	Paris		France	75679
10	University Clinic Heidelberg, Klinik für Anaesthesiologie, Im Neuenheimer Feld 110	Heidelberg	Baden-Württemberg	Germany	69120
11	Universitatsklinikum Leipzig, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Liebigstraße 20	Leipzig	Sachsen	Germany	04103
12	Universitatsklinikum Munster, Albert-Schweitzer-Campus 1	Münster		Germany	48149