Pharmacology of Aminophylline for Acute Kidney Injury in Neonates
Terminated
- Conditions
- Acute Kidney Injury
- Registration Number
- NCT02276170
- Lead Sponsor
- Stanford University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
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.
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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).
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug concentrations of theophylline Day 1 or 2 and Day 3,4, or 5
- Secondary Outcome Measures
Name Time Method Change in serum creatinine level Day 1,2,3,4,5 Number of participants with adverse events 5 days Change in urine biomarker levels Day 1,2,3,4,5 Change in renal Near-infrared spectroscopy (NIRS) Day 1,2,3,4 Change in urine output Day 1,2,3,4
Trial Locations
- Locations (1)
Lucile Packard Children's Hospital Stanford
🇺🇸Palo Alto, California, United States