Clinical trial NCT06652100: Establishment of ProNephro AKI (NGAL) Cut Off Value for Risk Assessment of Moderate to Severe Acute Kidney Injury in Adults
Official title: Establishment of ProNephro AKI (NGAL) Cut Off Value for Risk Assessment of Moderate to Severe Acute Kidney Injury in Adults (EPACRA-AKI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Keywords: NGAL
ICU
adult
Lead sponsor: BioPorto Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: ProPharma Group
First posted: 2024-10-22
Enrollment: 800
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU 22 years of age and older

Brief summary: The purpose of this research is to collect blood and urine from adult patients admitted to an intensive care unit. This is to assess the performance of the ProNephro AKI (NGAL) assay (lab test) as an aid to identify patients at risk for acute kidney injury.


Eligibility criteria: Inclusion Criteria:

Male and females ≥ 22 years of age. Subjects must be admitted to an Intensive Care Unit and must have a urine sample collected within 24 hours of ICU admission.

Subjects must have at least one of the following leading to admission to the ICU, or occurring within 24 hours of admission to the ICU:

* Vasoactive medication administration
* Mechanical ventilation
* Hypoxemia requiring oxygen support therapy including Bilevel positive airway pressure (BIPAP) and high flow nasal canula
* Mean arterial pressure (MAP) less than 60 (within 12 hrs. of ICU admission only)
* Serum Lactate greater than 2.5 mmol/L
* History of solid organ transplantation, renal transplantation included only if more than 3 months prior
* History of bone marrow transplantation Subject with signed informed consent.

Exclusion Criteria:

Special populations including pregnant and lactating women, prisoners, or institutionalized individuals.

Subjects receiving Kidney Replacement Therapy in the first 24 hours of ICU admission.

Subjects diagnosed with active Urinary Tract Infection per institute standard of care at the time of NGAL sampling.

Subjects with a known history of chronic kidney disease stages 4 and 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73M2 and under the care of a nephrologist.

Subjects with any known urothelial, urological or kidney malignancies. Subjects that have had any urologic procedure or urologic surgery immediately prior to admission to the ICU.

Subjects that have had surgical nephrectomy less than 3 months prior to admission.

Subjects that have been previously enrolled in this study. Subjects that do not have a baseline sCR within 6 months prior to ICU admission available.

Subjects that did not sign the informed consent. Subjects enrolled in an interventional pharmaceutical or device clinical trial at time of ICU admission

Primary outcomes:
measure: Cut off Establishment
timeFrame: 24hrs after ICU admission
Secondary outcomes:
measure: Sub-Group analysis
timeFrame: 24hrs after ICU admission
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama
state: Alabama
city: Sacramento
country: United States
facility: UC Davis
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: New York
country: United States
facility: Columbia University
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: