[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443547":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":10,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Duke University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Children (\u003C21 years of age) who are prescribed drugs of interest",null,"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",[13],"Drug: The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.","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.",[9],[21,22,23,24],"Methadone","Caffeine","Acetaminophen","Milrinone",[26],{"name":27,"affiliation":28,"role":29},"Christoph P Hornik, MD, PhD, MPH","Duke UMC","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"Stefany Olague, MPH","CONTACT","9196688131","smalltrials-CRC@duke.edu",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Duke University Medical Center","RECRUITING","Durham","North Carolina","27705","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-78.89862,35.99403,{"lat":49,"lon":48},[52],{"name":53,"role":33,"phone":10,"phoneExt":10,"email":10},"Liz Thompson, MD",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[57],{"name":58,"class":59},"Food and Drug Administration (FDA)","FED","100443547","opportunistic-pkpd-trial-in-critically-ill-children-optic-100443547",false,"NCT05055830","Opportunistic PK\u002FPD Trial in Critically Ill Children (OPTIC)","Clinically Integrated Opportunistic PK\u002FPD Trial in Critically Ill Children","OPTIC","Inclusion Criteria:\n\nTo be eligible for enrollment, a potential participant must meet all the following criteria:\n\n1. Participant is \\\u003C21 years old on admission\n2. Participant is admitted to the Pediatric Cardiac Intensive Care Unit\n3. Parent\u002Flegal guardian\u002Fadult participant can understand the consent process and is willing to provide informed consent\u002Fassent\n4. Participant is receiving one or more of the study drugs of interest at the time of enrollment\n\nExclusion Criteria:\n\n1\\. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study","ALL","0 Months","20 Years",{"count":72,"type":73},2000,"ESTIMATED","OBSERVATIONAL","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.\n\nAfter the child\u002Fadult (\\\u003C21 years of age) is consented\u002Fenrolled, demographic and clinical data will be extracted from the EHR. Biospecimen information (including date and time of sample collection) will be collected.\n\nData analysis will be conducted on all participants with at least 2 evaluable samples. The protocol represents minimal risk to the children\u002Fadults 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)\u002FSerious Adverse Events (SAEs) caused by the study specimen collections will be monitored and recorded in the Electronic Data Capture (EDC) system.",[77,78,79],"Cardiac Disease","Critically Ill","Children, Adult","2025-11-13",{"date":82,"type":83},"2025-11-14","ACTUAL",{"date":85,"type":83},"2021-10-05",{"date":87,"type":73},"2028-10-30",{"name":5,"class":6},1]