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

Cardiac Disease Clinical Trial

Official title:
Clinically Integrated Opportunistic PK/PD Trial in Critically Ill Children

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05055830
Study type Observational
Source Duke University
Contact Stefany Olague, MPH
Phone 9196688131
Email smalltrials-CRC@duke.edu
Status Recruiting
Phase
Start date October 5, 2021
Completion date September 30, 2025
View Details
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