Clinical trial NCT04434209: 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)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sepsis
Acute Kidney Injury
Septic Shock
Keywords: Sepsis
Acute Kidney Injury
Kidney damage
Septic shock
Biomarkers
Lead sponsor: BioMérieux
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Number of deaths, dialysis or progression of AKI
timeFrame: Enrollment to 72 hours
Secondary outcomes:
measure: Number of participants with progression of AKI
timeFrame: Enrollment to 48 and 72 hours
measure: Number of deaths
timeFrame: Enrollment to 48 and 72 hours
measure: Number of participants receiving dialysis
timeFrame: Enrollment to 48 and 72 hours
measure: Number participants at Stage 2 or 3 AKI
timeFrame: Enrollment to 72 hours
measure: ICU length of stay
timeFrame: Enrollment to hospital discharge or Day 60, whichever is sooner
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: LSU Health Sciences Center, 1541 Kings Highway
state: Louisiana
city: Boston
country: United States
facility: Brigham and Womens Hospital, 75 Francis Street
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center, 1275 York Avenue
state: New York
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende, Intensieve Zorgen, Ruddershove 10
state: West-Vlaanderen
city: Bruxelles
country: Belgium
facility: Hôpital Erasme, Soins Intensifs, Route de Lennik 808
city: Angers
country: France
facility: CHU Angers, 4 Rue Larrey
state: Maine-et-Loire
city: Béthune
country: France
facility: Centre Hospitalier de Béthune, Service de Réanimation et Surveillance continue, 27 rue Delbecque
state: Pas-de-Calais
city: Dijon
country: France
facility: CHRU Dijon Complexe Du Bocage, Department Infectiologie, 14 rue Gaffarel
city: Paris
country: France
facility: Hopital Cochin, 27 Rue Du Faubourg Saint Jacques
city: Heidelberg
country: Germany
facility: University Clinic Heidelberg, Klinik für Anaesthesiologie, Im Neuenheimer Feld 110
state: Baden-Württemberg
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Liebigstraße 20
state: Sachsen
city: Münster
country: Germany
facility: Universitatsklinikum Munster, Albert-Schweitzer-Campus 1
Study officials:
affiliation: Center for Critical Care Nephrology, University of Pittsburgh Medical Center
name: Hernando Gomez, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.