Observational study on drug use in critically ill children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The OPTIC study is an observational, open-label trial that aims to collect pharmacokinetic (PK) data on medications routinely administered to critically ill children in the Pediatric Cardiac Intensive Care Unit (PCICU). Approximately 2000 participants under the age of 21 will be enrolled, and their demographic and clinical data will be extracted from electronic health records. The study will utilize opportunistic and scavenged samples to analyze the PK of understudied drugs, with minimal risk to participants involved. The prescribing of medications will not be influenced by the study protocol.

Why it matters

Who can join: the full rules

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

Where it's running

• Duke University Medical Center
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Christoph P Hornik, MD, PhD, MPH — Duke University
• Study coordinator: Stefany Olague, MPH
• Email: smalltrials-CRC@duke.edu
• Phone: 9196688131

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.