Cardiac DiseaseOPTICNCT05055830
Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
An observational study of Cardiac Disease and Critically Ill, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 0 months to 20 years
- Conditions the study is for
- Cardiac Disease, Critically Ill, Children, Adult
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 30 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children under 21 years of age
Who may be able to join
- To be eligible for enrollment, a potential participant must meet all the following criteria:
- Participant is <21 years old on admission
- Participant is admitted to the Pediatric Cardiac Intensive Care Unit
- Parent/legal guardian/adult participant can understand the consent process and is willing to provide informed consent/assent
- Participant is receiving one or more of the study drugs of interest at the time of enrollment
Who cannot join
- 1. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27705
Elizabeth Thompson, MD
About this study
Official title: Clinically Integrated Opportunistic PK/PD Trial in Critically Ill Children
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.
- Conditions
- Cardiac Disease, Critically Ill, Children, Adult
- Being tested
- The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.
- Medical subject headings
- Heart Diseases, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.Drug
Also called Methadone, Caffeine, Acetaminophen, Milrinone
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.
| Study group | Role | What they receive |
|---|---|---|
| Children (<21 years of age) who are prescribed drugs of interest | 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 Receives: Drug: The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling
Measured: Data will be collected up to 180 days from the time of consent
Half-life (t1/2) as measured by PK sampling
Measured: 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
Measured: Data will be collected up to 180 days from the time of consent
AUC (area under the curve) as measured by PK sampling
Measured: Data will be collected up to 180 days from the time of consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start5 Oct 2021
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA), Burroughs Wellcome, Thrasher Research Fund, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Christoph P Hornik, MD, PhD, MPH, Principal investigator, Duke UniversityElizabeth Thompson, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055830
- Sponsor's protocol ID
- Pro00108566
- Acronym
- OPTIC
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thompson EJ, Foote HP, Hill KD, Hornik CP. A point-of-care pharmacokinetic/pharmacodynamic trial in critically ill children: Study design and feasibility. Contemp Clin Trials Commun. 2023 Jul 7;35:101182. doi: 10.1016/j.conctc.2023.101182. eCollection 2023 Oct.
PubMed 37485397
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinically Integrated Opportunistic PK/PD Trial in Critically Ill Children
- ClinicalTrials.gov ID
- NCT05055830
- Acronym / sponsor ID
- OPTIC / Pro00108566
- Conditions
- Cardiac Disease, Critically Ill, Children, Adult
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA), Burroughs Wellcome, Thrasher Research Fund, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children (<21 years of age) who are prescribed drugs of interest | – | Drug: 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 |
Who may qualify
- Ages
- 0 months to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children under 21 years of age
Key inclusion criteria (5 listed)
- To be eligible for enrollment, a potential participant must meet all the following criteria:
- Participant is <21 years old on admission
- Participant is admitted to the Pediatric Cardiac Intensive Care Unit
- Parent/legal guardian/adult participant can understand the consent process and is willing to provide informed consent/assent
- Participant is receiving one or more of the study drugs of interest at the time of enrollment
Key exclusion criteria (1 listed)
- 1. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.Also: Methadone, Caffeine, Acetaminophen, MilrinoneThe 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. | Drug | Children (<21 years of age) who are prescribed drugs of interest |
Primary outcome
Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling
Time frame: Data will be collected up to 180 days from the time of consent
Half-life (t1/2) as measured by PK sampling
Time frame: 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
Time frame: Data will be collected up to 180 days from the time of consent
AUC (area under the curve) as measured by PK sampling
Time frame: Data will be collected up to 180 days from the time of consent
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 37485397Thompson EJ, Foote HP, Hill KD, Hornik CP. A point-of-care pharmacokinetic/pharmacodynamic trial in critically ill children: Study design and feasibility. Contemp Clin Trials Commun. 2023 Jul 7;35:101182. doi: 10.1016/j.conctc.2023.101182. eCollection 2023 Oct.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christoph P Hornik, MD, PhD, MPH principal investigator
Duke University
Elizabeth Thompson, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease and Critically Ill, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefany Olague, MPH (9196688131, smalltrials-CRC@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling (time frame: Data will be collected up to 180 days from the time of consent). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05055830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.