NCT05055830 Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
| NCT ID | NCT05055830 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Cardiac Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2021-10-05 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2021-10-05 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
OPTIC is a prospective, open-label, non-randomized study of multiple medications administered to approximately 2000 children in the pediatric cardiac intensive care unit (PCICU) per routine clinical car by their treating provider. The purpose of this study is to characterize the PK of drugs routinely administered to children per standard of care using opportunistic and scavenged samples. The prescribing of drugs to children will not be part of this protocol. After the child/adult (\<21 years of age) is consented/enrolled, demographic and clinical data will be extracted from the EHR. Biospecimen information (including date and time of sample collection) will be collected. Data analysis will be conducted on all participants with at least 2 evaluable samples. The protocol represents minimal risk to the children/adults who provide body fluid for this study, including potential loss of confidentiality (samples will be assigned a unique accession number) and risks associated with blood draws. Adverse Events (AEs)/Serious Adverse Events (SAEs) caused by the study specimen collections will be monitored and recorded in the Electronic Data Capture (EDC) system.
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
Contact & Investigator
Christoph P Hornik, MD, PhD, MPH
PRINCIPAL INVESTIGATOR
Duke UMC
Frequently Asked Questions
Who can join the NCT05055830 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 20 Years, studying Cardiac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05055830 currently recruiting?
Yes, NCT05055830 is actively recruiting participants. Contact the research team at smalltrials-CRC@duke.edu for enrollment information.
Where is the NCT05055830 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT05055830 clinical trial?
NCT05055830 is sponsored by Duke University. The principal investigator is Christoph P Hornik, MD, PhD, MPH at Duke UMC. The trial plans to enroll 2,000 participants.