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PK/PD of Digoxin in Infants With SVHD
Sponsor: Duke University
Summary
The primary participant will be an infant with single ventricle heart disease. This is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in pediatric cardiac intensive care units is processed by their bodies and how it may help their cardiac function. The investigators will collect blood or will collect blood samples when bloodwork is checked as part of regular care ("opportunistic"). The investigators will also collect information from medical records. Being part of this study will not change treatment plan or medications. The risks of this study include loss of confidentiality and risks associated with having blood drawn. The study team will make every effort to minimize these risks.
Official title: Pharmacokinetics and Pharmacodynamics of Digoxin in Infants With Single Ventricle Heart Disease
Key Details
Gender
All
Age Range
30 Days - 6 Months
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-10-10
Completion Date
2026-11-30
Last Updated
2026-01-30
Healthy Volunteers
No
Interventions
PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease
Table 3: Digoxin dosing regimen based on optimized Cmin,ss Dose to be given twice daily (mcg/kg/dose) PNA\<30 days 30 days \< PNA \< 180 days eGFR≤40 1.4 1.4 40\<eGFR≤60 1.6 1.6 eGFR\>60 1.9 2.8
Locations (2)
Duke University Medical Center
Durham, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States