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

Launched by DUKE UNIVERSITY · Sep 15, 2021

Keywords

ClinConnect Summary

The OPTIC trial is a study looking into how certain medications work in critically ill children who are in the Pediatric Cardiac Intensive Care Unit (PCICU). The goal is to better understand how these drugs behave in the body, which can help improve treatment for kids with heart conditions. The study will involve around 2,000 children under the age of 21, and while they will continue to receive their prescribed medications as usual, the trial will collect samples of their body fluids to analyze how the medications are processed.

To be eligible for the study, participants need to be under 21 years old, admitted to the PCICU, and receiving at least one of the medications being studied. Parents or guardians will need to provide consent for their child to participate. Those who join the study can expect their health information to be collected, and blood samples to be taken, which carries minimal risk. The trial is designed to ensure participant privacy and safety, and any side effects from the sample collection will be monitored. This research aims to enhance our understanding of drug use in young patients, ultimately leading to better care.

Gender

ALL

Eligibility criteria

• 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