Observational study on drug use in critically ill children
Clinically Integrated Opportunistic PK/PD Trial in Critically Ill Children
This study looks at how different medications work in critically ill children in the Pediatric Cardiac Intensive Care Unit to better understand their effects and safety.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 0 Months to 20 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05055830 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 21 years old who are admitted to the Pediatric Cardiac Intensive Care Unit and are receiving one or more of the study drugs.
Not a fit: Patients who are not admitted to the Pediatric Cardiac Intensive Care Unit or are over 21 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of drug dosing and efficacy in critically ill pediatric patients, leading to improved treatment outcomes.
How similar studies have performed: While this study focuses on understudied drugs in a specific population, similar observational studies have shown success in characterizing drug pharmacokinetics in pediatric patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Christoph P Hornik, MD, PhD, MPH — Duke UMC
- Study coordinator: Stefany Olague, MPH
- Email: smalltrials-CRC@duke.edu
- Phone: 9196688131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.