[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05055830":3,"trial-entities:NCT05055830":91,"trial-summary:NCT05055830":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":17,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":58,"locations":61,"central_contacts":75,"overall_officials":80,"references":85,"see_also_links":90},"NCT05055830","Pro00108566","Opportunistic PK\u002FPD Trial in Critically Ill Children (OPTIC)","Clinically Integrated Opportunistic PK\u002FPD Trial in Critically Ill Children","RECRUITING","2028-10-30","2025-11","2025-11-14","2021-10-05","Duke University","OTHER",false,"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.",null,[19,20,21],"Cardiac Disease","Critically Ill","Children, Adult",[],"OBSERVATIONAL",[],{"count":26,"type":27},2000,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"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.",[34],"Children (\u003C21 years of age) who are prescribed drugs of interest",[36,37,38,39],"Methadone","Caffeine","Acetaminophen","Milrinone",[41,44,46,48],{"measure":42,"timeFrame":43},"Clearance (CL) or apparent oral clearance (CL\u002FF) as measured by PK sampling","Data will be collected up to 180 days from the time of consent",{"measure":45,"timeFrame":43},"Half-life (t1\u002F2) as measured by PK sampling",{"measure":47,"timeFrame":43},"Volume of distribution (V) or apparent oral volume of distribution (V\u002FF) as measured by PK sampling",{"measure":49,"timeFrame":43},"AUC (area under the curve) as measured by PK sampling",[],"ALL","0 Months","20 Years",{"inclusion":55,"exclusion":56,"raw_text":57},[],[],"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",[59,60],"CHILD","ADULT",[62],{"facility":63,"status":8,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":72},"Duke University Medical Center","Durham","North Carolina","27705","United States",[69],{"name":70,"role":71},"Liz Thompson, MD","CONTACT",{"lat":73,"lon":74},35.99403,-78.89862,[76],{"name":77,"role":71,"phone":78,"email":79},"Stefany Olague, MPH","9196688131","smalltrials-CRC@duke.edu",[81],{"name":82,"affiliation":83,"role":84},"Christoph P Hornik, MD, PhD, MPH","Duke UMC","PRINCIPAL_INVESTIGATOR",[86],{"pmid":87,"type":88,"citation":89},"37485397","DERIVED","Thompson EJ, Foote HP, Hill KD, Hornik CP. A point-of-care pharmacokinetic\u002Fpharmacodynamic trial in critically ill children: Study design and feasibility. Contemp Clin Trials Commun. 2023 Jul 7;35:101182. doi: 10.1016\u002Fj.conctc.2023.101182. eCollection 2023 Oct.",[],{"nct_id":4,"conditions":92,"biomarkers":95},[93,94],"Critical Illness","Heart Disorder",[],{"nct_id":4,"found":97,"summary":98,"prompt_version":108},true,{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is an observational study, meaning researchers will collect information about medications already being given as part of routine care. It is an open-label study, so everyone involved will know what medications are being used. Approximately 2000 children are expected to participate.","completed","OPTIC Study: Understanding Drug Effects in Critically Ill Children","This observational study, called OPTIC, is looking at how certain medications work in critically ill children and young adults (up to 20 years old) who are admitted to the Pediatric Cardiac Intensive Care Unit. The study aims to understand how the body processes these medications, specifically their clearance (how quickly the body removes the drug), half-life (how long it takes for half of the drug to leave the body), and volume of distribution (how the drug spreads throughout the body). This information will help doctors better understand how to dose these drugs, as current recommendations are often lacking for children. You would be eligible if you are under 21 years old, in the PCICU, and your parent\u002Fguardian can provide consent. This study is not testing new drugs; it's observing how existing drugs are used in routine care. The study plans to include about 2000 participants.","Participants will be followed for up to 180 days from the time of consent to measure drug levels.",145,"The study will collect information from your medical records and use blood samples already drawn for routine medical care. Data will be collected for up to 180 days from when consent is given.","Not stated in the trial record.",[],"v2"]