NGAL Usage In Determining AKI Risk in Critically Ill Children
C
Christopher Mastropietro, MD
Primary Investigator
Enrolling By Invitation
3-22 years
All
Phase
N/A
500 participants needed
1 Location
Brief description of study
This is a prospective, observational, non-significant risk clinical study to validate the performance of BioPorto Diagnostics’ The NGAL TestTM in patients aged ≥ 90 days to < 22 years of age that have been admitted to the Pediatric Intensive Care Unit (PICU) with at least one of the following within the first 12 hours of PICU admission : • Vasoactive medication administration
• Mechanical ventilation
• History of solid organ transplantation, renal transplantation included only if more than 3 months prior
• History of bone marrow transplantation
• Hypotension, defined as having received ≥ 40 ml/kg of resuscitative fluid in pre-ICU (within 6 hours prior to ICU admission) or in first 12 hours of ICU admission
Detailed description of study
A pediatric urine sample is spun down to remove cellular debris and the supernatant is then mixed with reaction buffer (R1). After a short incubation, the reaction is started by the addition of an immunoparticle suspension (microparticles coated with mouse monoclonal antibodies to NGAL) (R2). NGAL in the sample causes the immunoparticles to agglutinate. The degree of agglutination is quantified by the amount of light scattering measured as absorption of light at a wavelength of 570 nm. The absorbance change is read approximately six minutes after the addition of R2. The NGAL concentration in the sample is determined by interpolation on a calibration curve prepared from calibrators of known concentrations.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: solid organ transplant; bone marrow transplant; hypotension
-
Age: Between 3 Months - 22 Years
-
Gender: All
Inclusion Criteria:
- • Aged ≥90 days to < 22 years of age.
- • Subjects must be admitted to a Pediatric Intensive Care Unit and must be enrolled into this study within 12 hours of receipt of ICU admission orders (and sample collection to take place between 4 and 12 hours of admission).
- • Subjects must have at least one of the following leading to admission to the PICU, or occurring within 12 hours of admission to the PICU:
- o Vasoactive medication administration
- o Mechanical ventilation
- o History of solid organ transplantation, renal transplantation included only if more than 3 months prior
- o History of bone marrow transplantation
- o Hypotension, defined as having received ≥ 40 ml/kg of resuscitative fluid in pre-ICU
- (within 6 hours prior to ICU admission) or in first 12 hours of ICU admission
Exclusion Criteria:
- • Subjects receiving Renal Replacement Therapy in the first 24 hours of ICU admission.
- • Subjects with a diagnosed active Urinary Tract Infection 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 pediatric nephrologist.
- • Subjects with known congenital anomalies of the kidney and urinary tract at the time of presentation to the PICU.
- • 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 PICU.
- • Subjects that have had surgical nephrectomy less than 3 months prior to admission.
- • Subjects admitted to the pediatric ICU immediately post-operatively or up to three months following surgical correction of congenital heart disease.
- • Subjects with uncorrected congenital heart disease. This criterion does not include patients with isolated uncorrected ventricular septal defect (VSD), atrial septal defect (ASD), patent ductus arteriosus (PDA) and patent foramen ovale (PFO).
Updated on
01 Aug 2024.
Study ID: 2010483979; TD27373
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
