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 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.
Conditions:
🦠 Cardiac Disease 🦠 Critically Ill 🦠 Children, Adult
🗓️ Study Start (Actual) 5 October 2021
🗓️ Primary Completion (Estimated) 30 September 2024
✅ Study Completion (Estimated) 30 September 2025
👥 Enrollment (Estimated) 2000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    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 Eligible for Study: 0 Months to 20 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 September 2021
  • First Submitted that Met QC Criteria 15 September 2021
  • First Posted 24 September 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 September 2023
  • Last Update Posted 28 September 2023
  • Last Verified September 2023