Acute Kidney Injury
Conditions
Brief summary
Acute kidney injury (AKI) in critically ill neonates is common and associated with significant morbidity and mortality. No targeted therapeutic treatment strategies have been established for AKI in neonates. Within a clinical pharmacokinetic and pharmacodynamic conceptual framework, this project will examine the medication aminophylline as a potential treatment approach for AKI.
Interventions
None listed
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No
Inclusion criteria
* Neonate \< 3 months post natal age * Diagnosed with acute kidney injury (AKI) * Receiving aminophylline for AKI treatment as per local standard of care.
Exclusion criteria
* Presence of anatomical renal anomaly based on postnatal evaluation of the patient (hydronephrosis, multicystic kidney, renal agenesis, renal dysplasia, polycystic kidney, or obstructive uropathy) * Patient on renal replacement therapy * Major genetic abnormalities (trisomy 13, 18 or 21).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentrations of theophylline | Day 1 or 2 and Day 3,4, or 5 |
Secondary
| Measure | Time frame |
|---|---|
| Change in renal Near-infrared spectroscopy (NIRS) | Day 1,2,3,4 |
| Change in urine output | Day 1,2,3,4 |
| Number of participants with adverse events | 5 days |
| Change in urine biomarker levels | Day 1,2,3,4,5 |
| Change in serum creatinine level | Day 1,2,3,4,5 |
Countries
United States
Outcome results
None listed