Purpose

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.

Condition

Eligibility

Eligible Ages
Over 22 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Jevon Robinson
617-724-4028
jrobinson39@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
BioPorto Diagnostics

Study Contact

Ute Feger Director Clinical Affairs, PhD
844-424-6767
ClinicalAffairs@bioporto.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.