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/37485397/Actively Recruiting
Led by Duke University · Updated on 2025-11-14
2000
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
S
Stefany Olague, MPH
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Duke University
Lead Sponsor
Food and Drug Administration (FDA)
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Elizabeth J Thompson, Henry P Foote, Kevin D Hill...
https://pubmed.ncbi.nlm.nih.gov/37485397/Duke University
Lead Sponsor
Food and Drug Administration (FDA)
Collaborating Sponsor