Opportunistic PK/PD Trial in Critically Ill Children (OPTIC) (OPTIC)

Clinically Integrated Opportunistic PK/PD Trial in Critically Ill Children

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 Overview

• Status: Recruiting
• Conditions: Critically Ill; Cardiac Disease; Children, Adult
• Intervention / Treatment: Drug: The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Stefany Olague, MPH; Phone Number: 9196688131; Email: smalltrials-CRC@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University Medical Center
      • Contact: Liz Thompson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children under 21 years of age

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Children (<21 years of age) who are prescribed drugs of interest; Children and young adults who are prescribed drugs of interest as part of their routine medical care and are admitted to the pediatric cardiac intensive care unit

Drug: The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.; The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws), this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care.; Other Names: Acetaminophen; Milrinone; Caffeine; Methadone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling	Data will be collected up to 180 days from the time of consent
Half-life (t1/2) as measured by PK sampling	Data will be collected up to 180 days from the time of consent
Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling	Data will be collected up to 180 days from the time of consent
AUC (area under the curve) as measured by PK sampling	Data will be collected up to 180 days from the time of consent

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Food and Drug Administration (FDA)
• Investigators: Principal Investigator: Christoph P Hornik, MD, PhD, MPH, Duke UMC

Publications and helpful links

General Publications

• Thompson EJ, Foote HP, Hill KD, Hornik CP. A point-of-care pharmacokinetic/pharmacodynamic trial in critically ill children: Study design and feasibility. Contemp Clin Trials Commun. 2023 Jul 7;35:101182. doi: 10.1016/j.conctc.2023.101182. eCollection 2023 Oct.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness; Heart Diseases; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Alkaloids; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Purinones; Purines; Aminopyridines; Amrinone; Ketones; Xanthines; Acetaminophen; Caffeine; Methadone; Milrinone
• Other Study ID Numbers: Pro00108566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No