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

NCT05055830 | Recruiting

• 1 other identifier: Pro00108566
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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.

Interventions

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.

Also known as: Methadone, Caffeine, Acetaminophen, Milrinone

Children (<21 years of age) who are prescribed drugs of interest

Eligibility Criteria

• Age: 0 Months - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children under 21 years of age

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 37485397 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, effluent samples, tissue, and plasma

MeSH Terms

Conditions

Heart Diseases; Critical Illness

Interventions

Methadone; Caffeine; Acetaminophen; Milrinone

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Amrinone; Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Christoph P Hornik, MD, PhD, MPH

  Duke UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefany Olague, MPH

CONTACT

9196688131; smalltrials-CRC@duke.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 24, 2021
• Study Start: October 5, 2021
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)