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NCT Number: NCT05055830

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.

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Children, Adult Critical Illness Critically Ill Disease Attributes Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

0 month–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Liz Thompson, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be eligible for enrollment, a potential participant must meet all the following criteria:

  • Participant is <21 years old on admission
  • Participant is admitted to the Pediatric Cardiac Intensive Care Unit
  • Parent/legal guardian/adult participant can understand the consent process and is willing to provide informed consent/assent
  • Participant is receiving one or more of the study drugs of interest at the time of enrollment

Exclusion criteria

  • Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Treatment and study plan

The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.

Drug

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: Methadone, Caffeine, Acetaminophen, Milrinone

Primary outcomes

  1. Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling

    Time frame: Data will be collected up to 180 days from the time of consent

  2. Half-life (t1/2) as measured by PK sampling

    Time frame: Data will be collected up to 180 days from the time of consent

  3. Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling

    Time frame: Data will be collected up to 180 days from the time of consent

  4. AUC (area under the curve) as measured by PK sampling

    Time frame: Data will be collected up to 180 days from the time of consent

Study contacts

Contact information is provided by the study sponsor or research team.

Stefany Olague, MPH

CONTACT

[email protected]

9196688131

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Food and Drug Administration (FDA)

Registry information

Official study title

Clinically Integrated Opportunistic PK/PD Trial in Critically Ill Children

Acronym: OPTIC

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Sep 24, 2021
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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