Cardiac Disease, Children, Adult, Critically Ill
Conditions
Brief summary
OPTIC is a prospective, open-label, non-randomized study of multiple medications administered to approximately 2000 children in the pediatric cardiac intensive care unit (PCICU) per routine clinical car by their treating provider. The purpose of this study is to characterize the PK of drugs routinely administered to children per standard of care using opportunistic and scavenged samples. The prescribing of drugs to children will not be part of this protocol. After the child/adult (\<21 years of age) is consented/enrolled, demographic and clinical data will be extracted from the EHR. Biospecimen information (including date and time of sample collection) will be collected. Data analysis will be conducted on all participants with at least 2 evaluable samples. The protocol represents minimal risk to the children/adults who provide body fluid for this study, including potential loss of confidentiality (samples will be assigned a unique accession number) and risks associated with blood draws. Adverse Events (AEs)/Serious Adverse Events (SAEs) caused by the study specimen collections will be monitored and recorded in the Electronic Data Capture (EDC) system.
Interventions
DRUGThe OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.
The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws), this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care.
Sponsors
Food and Drug Administration (FDA)
Duke University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Months to 20 Years
Healthy volunteers
No
Inclusion criteria
To be eligible for enrollment, a potential participant must meet all the following criteria: 1. Participant is \<21 years old on admission 2. Participant is admitted to the Pediatric Cardiac Intensive Care Unit 3. Parent/legal guardian/adult participant can understand the consent process and is willing to provide informed consent/assent 4. Participant is receiving one or more of the study drugs of interest at the time of enrollment
Exclusion criteria
1\. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling | Data will be collected up to 180 days from the time of consent |
| Half-life (t1/2) as measured by PK sampling | Data will be collected up to 180 days from the time of consent |
| Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling | Data will be collected up to 180 days from the time of consent |
| AUC (area under the curve) as measured by PK sampling | Data will be collected up to 180 days from the time of consent |
Countries
United States
Contacts
Primary ContactStefany Olague, MPH
Outcome results
None listed