SepsisLAPISNCT04434209
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)
A study testing Subject management guided by NephroCheck® test in people with Sepsis and Acute Kidney Injury, run by BioMérieux at 12 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sepsis, Acute Kidney Injury, Septic Shock
- What is being tested?
- Subject management guided by NephroCheck® test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 19 Jan 2021to 14 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
France4 sites
CHU Angers, 4 Rue Larrey
Angers, Maine-et-Loire, 49100
Centre Hospitalier de Béthune, Service de Réanimation et Surveillance continue, 27 rue Delbecque
Béthune, Pas-de-Calais, 62408
CHRU Dijon Complexe Du Bocage, Department Infectiologie, 14 rue Gaffarel
Dijon, 21079
Hopital Cochin, 27 Rue Du Faubourg Saint Jacques
Paris, 75679
United States3 sites
Brigham and Womens Hospital, 75 Francis Street
Boston, Massachusetts, 02115
Memorial Sloan Kettering Cancer Center, 1275 York Avenue
New York, New York, 10065
LSU Health Sciences Center, 1541 Kings Highway
Shreveport, Louisiana, 71130
Germany3 sites
University Clinic Heidelberg, Klinik für Anaesthesiologie, Im Neuenheimer Feld 110
Heidelberg, Baden-Wurttemberg, 69120
Universitatsklinikum Leipzig, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Liebigstraße 20
Leipzig, Saxony, 04103
Universitatsklinikum Munster, Albert-Schweitzer-Campus 1
Münster, 48149
Belgium2 sites
AZ Sint-Jan Brugge-Oostende, Intensieve Zorgen, Ruddershove 10
Bruges, West-Vlaanderen, 8000
Hôpital Erasme, Soins Intensifs, Route de Lennik 808
Brussels, 1070
About this study
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
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
- Being tested
- Subject management guided by NephroCheck® test, Standard of Care
- Keywords
- Sepsis, Acute Kidney Injury, Kidney damage, Septic shock, Biomarkers
- Medical subject headings
- Sepsis, Acute Kidney Injury, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subject management guided by NephroCheck® testDevice
NephroCheck® is a device using biomarkers to identify subjects at risk of sepsis-associated acute kidney injury
Standard of CareOther
Standard of Care patient management
| Study group | Role | What they receive |
|---|---|---|
| NephroCheck-guided interventions | Experimental | Not described Receives: Device: Subject management guided by NephroCheck® test |
| Standard of Care | Active comparator | Standard of Care assessment and treatment Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment to 72 hours
Secondary outcomes (5)
Number of participants with progression of AKI
Progression of AKI (Acute Kidney Injury) to Stage 2 or 3 during the time frame. Measured independently.
Measured: Enrollment to 48 and 72 hours
Number of deaths
Number of deaths. Measured independently.
Measured: Enrollment to 48 and 72 hours
Number of participants receiving dialysis
Dialysis defined as any form of renal replacement therapy (RRT). Measured independently.
Measured: Enrollment to 48 and 72 hours
Number participants at Stage 2 or 3 AKI
Defined as highest stage of AKI during the time frame
Measured: Enrollment to 72 hours
ICU length of stay
Measured: Enrollment to hospital discharge or Day 60, whichever is sooner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start19 Jan 2021
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
Why it stopped: Highly improbable to reach recruitment objective due to impact of COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMérieux
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hernando Gomez, MD, MPH, Principal investigator, Center for Critical Care Nephrology, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434209
- Sponsor's protocol ID
- LAPIS
- Acronym
- LAPIS
- Status last verified
- Feb 2025
- First submitted
- 26 May 2020
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 33927121
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04434209
- Acronym / sponsor ID
- LAPIS / LAPIS
- Conditions
- Sepsis, Acute Kidney Injury, Septic Shock
- Keywords
- Sepsis, Acute Kidney Injury, Kidney damage, Septic shock, Biomarkers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Highly improbable to reach recruitment objective due to impact of COVID-19 pandemic
- Enrolment
- 19 participants (actual)
- Lead sponsor
- BioMérieuxIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NephroCheck-guided interventions | Experimental | Device: Subject management guided by NephroCheck® test |
| Standard of Care | Active comparator | Other: Standard of CareStandard of Care assessment and treatment |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subject management guided by NephroCheck® testNephroCheck® is a device using biomarkers to identify subjects at risk of sepsis-associated acute kidney injury | Device | NephroCheck-guided interventions |
| Standard of CareStandard of Care patient management | Other | Standard of Care |
Primary outcome
Number of deaths, dialysis or progression of AKI
Time frame: 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.
5 secondary outcomes
Number of participants with progression of AKI
Time frame: Enrollment to 48 and 72 hours
Number of deaths
Time frame: Enrollment to 48 and 72 hours
Number of participants receiving dialysis
Time frame: Enrollment to 48 and 72 hours
Number participants at Stage 2 or 3 AKI
Time frame: Enrollment to 72 hours
ICU length of stay
Time frame: Enrollment to hospital discharge or Day 60, whichever is sooner
Results and safety
The study was stopped early (reason given: Highly improbable to reach recruitment objective due to impact of COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Derived from this study: PubMed 33927121Molinari 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.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hernando Gomez, MD, MPH principal investigator
Center for Critical Care Nephrology, University of Pittsburgh Medical Center
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subject management guided by NephroCheck® test in people with Sepsis and Acute Kidney Injury, run by BioMérieux at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, United States, Germany, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Highly improbable to reach recruitment objective due to impact of COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of deaths, dialysis or progression of AKI (time frame: Enrollment to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04434209, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.