Pharmacokinetics and Pharmacodynamics of Digoxin in Infants With Single Ventricle Heart Disease
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.
Description
Study design: Multi-center, prospective, open-label, opportunistic PK/PD study of digoxin. Randomization: none Blinding /Masking: none Study intervention: Each subject will receive population specific PK model-derived digoxin dosing Duration of participant participation: up to 180 days Table 1. PK sample collection times PK Sample # Sample window for plasma collection 1. 8 - 11.5 hours after dose / trough level on dosing Day 7 (+/- 2 days) 2. 15 minutes - 1 hour after dose on dosing Day ≥14 3. 2 - 5 hours after dose on dosing Day ≥14 4. 8 - 11.5 hours after dose / trough level on dosing Day…
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of single ventricle congenital heart disease 2. Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation 3. Age ≤ 30 days of life at time of stage 1 palliation 4. Age \< 6 months at time of enrollment 5. Require treatment with enteral digoxin per their treating medical provider 6. Informed consent obtained from parent(s) or legal guardian(s) Exclusion Criteria: 1. Gestational age at birth \<35 weeks 2. Serum creatinine \> 2 mg/dL at enrollment 3. Diagnosis of second degree or higher atrioventricular conduction block at enrol…
Interventions
- DrugPK/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 CenterDurham, North Carolina
- Medical University of South CarolinaCharleston, South Carolina