Back to resultsA Study Looking at the Use of Biomarkers to Provide Early Indication of Acute Kidney Injury in Patients With Sepsis (Limiting AKI Progression In Sepsis) (LAPIS)
Primary Purpose
Sepsis, Acute Kidney Injury, Septic Shock
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Subject management guided by NephroCheck® test
Standard of Care
Sponsored by
About this trial
This is an interventional diagnostic trial for Sepsis focused on measuring Sepsis, Acute Kidney Injury, Kidney damage, Septic shock, Biomarkers
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:
- 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.
Sites / Locations
- LSU Health Sciences Center, 1541 Kings Highway
- Brigham and Womens Hospital, 75 Francis Street
- Memorial Sloan Kettering Cancer Center, 1275 York Avenue
- AZ Sint-Jan Brugge-Oostende, Intensieve Zorgen, Ruddershove 10
- Hôpital Erasme, Soins Intensifs, Route de Lennik 808
- CHU Angers, 4 Rue Larrey
- Centre Hospitalier de Béthune, Service de Réanimation et Surveillance continue, 27 rue Delbecque
- CHRU Dijon Complexe Du Bocage, Department Infectiologie, 14 rue Gaffarel
- Hopital Cochin, 27 Rue Du Faubourg Saint Jacques
- University Clinic Heidelberg, Klinik für Anaesthesiologie, Im Neuenheimer Feld 110
- Universitatsklinikum Leipzig, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Liebigstraße 20
- Universitatsklinikum Munster, Albert-Schweitzer-Campus 1
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NephroCheck-guided interventions
Standard of Care
Arm Description
Standard of Care assessment and treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of participants with progression of AKI
Progression of AKI (Acute Kidney Injury) to Stage 2 or 3 during the time frame. Measured independently.
Number of deaths
Number of deaths. Measured independently.
Number of participants receiving dialysis
Dialysis defined as any form of renal replacement therapy (RRT). Measured independently.
Number participants at Stage 2 or 3 AKI
Defined as highest stage of AKI during the time frame
ICU length of stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04434209
Brief Title
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)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Highly improbable to reach recruitment objective due to impact of COVID-19 pandemic
Study Start Date
January 19, 2021 (Actual)
Primary Completion Date
February 14, 2022 (Actual)
Study Completion Date
February 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioMérieux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Acute Kidney Injury, Septic Shock
Keywords
Sepsis, Acute Kidney Injury, Kidney damage, Septic shock, Biomarkers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NephroCheck-guided interventions
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard of Care assessment and treatment
Intervention Type
Device
Intervention Name(s)
Subject management guided by NephroCheck® test
Intervention Description
NephroCheck® is a device using biomarkers to identify subjects at risk of sepsis-associated acute kidney injury
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care patient management
Primary Outcome Measure Information:
Title
Number of deaths, dialysis or progression of AKI
Description
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.
Time Frame
Enrollment to 72 hours
Secondary Outcome Measure Information:
Title
Number of participants with progression of AKI
Description
Progression of AKI (Acute Kidney Injury) to Stage 2 or 3 during the time frame. Measured independently.
Time Frame
Enrollment to 48 and 72 hours
Title
Number of deaths
Description
Number of deaths. Measured independently.
Time Frame
Enrollment to 48 and 72 hours
Title
Number of participants receiving dialysis
Description
Dialysis defined as any form of renal replacement therapy (RRT). Measured independently.
Time Frame
Enrollment to 48 and 72 hours
Title
Number participants at Stage 2 or 3 AKI
Description
Defined as highest stage of AKI during the time frame
Time Frame
Enrollment to 72 hours
Title
ICU length of stay
Time Frame
Enrollment to hospital discharge or Day 60, whichever is sooner
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hernando Gomez, MD, MPH
Organizational Affiliation
Center for Critical Care Nephrology, University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
LSU Health Sciences Center, 1541 Kings Highway
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Brigham and Womens Hospital, 75 Francis Street
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center, 1275 York Avenue
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
AZ Sint-Jan Brugge-Oostende, Intensieve Zorgen, Ruddershove 10
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Hôpital Erasme, Soins Intensifs, Route de Lennik 808
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
CHU Angers, 4 Rue Larrey
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49100
Country
France
Facility Name
Centre Hospitalier de Béthune, Service de Réanimation et Surveillance continue, 27 rue Delbecque
City
Béthune
State/Province
Pas-de-Calais
ZIP/Postal Code
62408
Country
France
Facility Name
CHRU Dijon Complexe Du Bocage, Department Infectiologie, 14 rue Gaffarel
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hopital Cochin, 27 Rue Du Faubourg Saint Jacques
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
University Clinic Heidelberg, Klinik für Anaesthesiologie, Im Neuenheimer Feld 110
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitatsklinikum Leipzig, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Liebigstraße 20
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitatsklinikum Munster, Albert-Schweitzer-Campus 1
City
Münster
ZIP/Postal Code
48149
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
33927121
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.
Results Reference
derived
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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)
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