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

Duke University

Status: Enrolling

Conditions: Critically Ill; Cardiac Disease; Children, Adult

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

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05055830

Pro00108566

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: Under 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 1 patient group

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

Description:

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

Treatment:

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