Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
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 ch
| Condition(s) | Cardiac Disease, Critically Ill, Children, Adult |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 r |
| Who can participate | 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 |
| Ages | 0 Months to 20 Years |
| Sex | All |
| Lead sponsor | Duke University |
| Locations | Durham, North Carolina, United States |
| Start date | 2021-10-05 |
| NCT ID | NCT05055830 |
| Official listing | https://clinicaltrials.gov/study/NCT05055830 |