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

Recruiting

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

• Registration Number: NCT05055830
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-24
• Study Start: 2021-10-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children (<21 years of age) who are prescribed drugs of interest	The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States