A point-of-care pharmacokinetic/pharmacodynamic trial in critically ill children: Study design and feasibility.
Elizabeth J Thompson, Henry P Foote, Kevin D Hill...
https://pubmed.ncbi.nlm.nih.gov/37485397Actively Recruiting
Age: 0Months - 20Years
All Genders
ID05055830
Clinically Integrated Opportunistic PK/PD Trial in Critically Ill Children
Led by Duke University · Updated on 2025-11-14
2000
Participants Needed
1
Research Sites
52 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
Researchers are investigating the pharmacokinetics (PK) of various medications routinely given to children and young adults under 21 years old in the pediatric cardiac intensive care unit (PCICU). The study aims to better understand how these drugs behave in the body, especially for those medications with limited safety and dosing information. This is an observational study where the prescribing of drugs is not influenced by the research. The study collects data from about 2000 children and young adults who are prescribed these drugs as part of their normal medical care. Researchers use leftover blood samples taken during routine medical procedures to analyze drug levels without additional risk. Enrollment includes gathering demographic and clinical information from electronic health records, along with details about the samples collected. Participants will be monitored for up to 180 days after consent for PK measures including drug clearance, half-life, volume of distribution, and area under the curve. The study involves minimal risk beyond standard care, with monitoring for any adverse events related to sample collection. This research helps build knowledge on drug use in critically ill pediatric populations while ensuring participant safety and confidentiality.
CONDITIONS
Brief Title
Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
Who Can Participate
Age: 0Months - 20Years
All Genders
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, or adult participant can understand the consent process and is willing to provide informed consent or 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 unsuitable for the study in the opinion of the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 180 days from the time of consent
Participants who undergo routine care are observed while receiving prescribed drugs of interest. Measurements are collected before and after routine healthcare procedures, including blood draws to gather pharmacokinetic data.
Visits aligned with routine medical care up to 180 days
Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27705
Actively Recruiting
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Research Team
S
Stefany Olague, MPH
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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