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)

Sepsis Clinical Trial

— LAPIS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04434209
• Other study ID #: LAPIS
• Status: Terminated
• Phase: Phase 4
• Start date: January 19, 2021
• Est. completion date: February 14, 2022

Study information

• Verified date: February 2022
• Source: BioMérieux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: February 14, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Sepsis
• Septic Shock
• Shock, Septic
• Toxemia

Intervention

Device:
• Subject management guided by NephroCheck® test
NephroCheck® is a device using biomarkers to identify subjects at risk of sepsis-associated acute kidney injury

Other:
• Standard of Care
Standard of Care patient management

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan Brugge-Oostende, Intensieve Zorgen, Ruddershove 10	Brugge	West-Vlaanderen
Belgium	Hôpital Erasme, Soins Intensifs, Route de Lennik 808	Bruxelles
France	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
Germany	University Clinic Heidelberg, Klinik für Anaesthesiologie, Im Neuenheimer Feld 110	Heidelberg	Baden-Württemberg
Germany	Universitatsklinikum Leipzig, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Liebigstraße 20	Leipzig	Sachsen
Germany	Universitatsklinikum Munster, Albert-Schweitzer-Campus 1	Münster
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	LSU Health Sciences Center, 1541 Kings Highway	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
BioMérieux

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with progression of AKI	Progression of AKI (Acute Kidney Injury) to Stage 2 or 3 during the time frame. Measured independently.	Enrollment to 48 and 72 hours
Secondary	Number of deaths	Number of deaths. Measured independently.	Enrollment to 48 and 72 hours
Secondary	Number of participants receiving dialysis	Dialysis defined as any form of renal replacement therapy (RRT). Measured independently.	Enrollment to 48 and 72 hours
Secondary	Number participants at Stage 2 or 3 AKI	Defined as highest stage of AKI during the time frame	Enrollment to 72 hours
Secondary	ICU length of stay		Enrollment to hospital discharge or Day 60, whichever is sooner