Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
Public ClinicalTrials.gov record NCT05055830. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Clinically Integrated Opportunistic PK/PD Trial in Critically Ill Children
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05055830
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 2,000 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 0 Months to 20 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 4, 2021
- Primary completion
- Oct 29, 2027
- Completion
- Oct 29, 2028
- Last update posted
- Nov 13, 2025
2021 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05055830, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 13, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05055830 live on ClinicalTrials.gov.