OPTIC Study: Understanding Drug Effects in Critically Ill Children

This observational study, called OPTIC, is looking at how certain medications work in critically ill children and young adults (up to 20 years old) who are admitted to the Pediatric Cardiac Intensive Care Unit. The study aims to understand how the body processes these medications, specifically their clearance (how quickly the body removes the drug), half-life (how long it takes for half of the drug to leave the body), and volume of distribution (how the drug spreads throughout the body). This information will help doctors better understand how to dose these drugs, as current recommendations are often lacking for children. You would be eligible if you are under 21 years old, in the PCICU, and your parent/guardian can provide consent. This study is not testing new drugs; it's observing how existing drugs are used in routine care. The study plans to include about 2000 participants.

Study design
This is an observational study, meaning researchers will collect information about medications already being given as part of routine care. It is an open-label study, so everyone involved will know what medications are being used. Approximately 2000 children are expected to participate.
What's involved
The study will collect information from your medical records and use blood samples already drawn for routine medical care. Data will be collected for up to 180 days from when consent is given.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 180 days from the time of consent to measure drug levels.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05055830

Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)

Recruiting
Not specifiedAges 0–20Observational
Duke University
~2,000 participants
Updated 2025-11-14 on ClinicalTrials.gov
What's tested:The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling
Measured over Data will be collected up to 180 days from the time of consent
+3 more outcomes measured
Cardiac Disease
Critically Ill
Children, Adult
1 sites across 1 states
North Carolina1
  • Christoph P Hornik, MD, PhD, MPH · PRINCIPAL_INVESTIGATOR · Duke UMC

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  • Clearance (CL) or apparent oral clearance (CL/F) as measured by PK samplingData will be collected up to 180 days from the time of consent
  • Half-life (t1/2) as measured by PK samplingData 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 samplingData will be collected up to 180 days from the time of consent
  • AUC (area under the curve) as measured by PK samplingData will be collected up to 180 days from the time of consent