Actively Recruiting
Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
Led by Duke University · Updated on 2025-11-14
2000
Participants Needed
1
Research Sites
368 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
F
Food and Drug Administration (FDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is younger than 21 years old on admission
- Participant is admitted to the Pediatric Cardiac Intensive Care Unit
- Parent/legal guardian/adult participant can understand the consent process and is willing to provide informed consent/assent
- Participant is receiving one or more of the study drugs of interest at the time of enrollment
You will not qualify if you...
- Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27705
Actively Recruiting
Research Team
S
Stefany Olague, MPH
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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