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NCT05055830 · ClinicalTrials.gov registry record
Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
A clinical trial of Cardiac Disease and Critically Ill, sponsored by Duke University.
- Recruiting
- Registry status
- 2,000
- Enrollment target
- 1
- Study location
NCT05055830 is a study of Cardiac Disease and Critically Ill that is actively recruiting participants, run by Duke University. The registered enrollment target is 2,000 participants, above the 739-participant average among 24 other Cardiac Disease trials with a reported enrollment target (171% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05055830, a study of Cardiac Disease and Critically Ill, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- 2,000 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2021-10-05 |
| Est. Completion | 2028-10-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05055830
The ClinicalTrials.gov registry entry for NCT05055830 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 739-participant average among 24 other Cardiac Disease trials with a reported enrollment target (171% higher). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Cardiac Disease appearing as the primary indexed condition, and to 1 intervention - of which The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care. is the first listed.
NCT05055830 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT05055830 about?
NCT05055830 is a clinical study titled "Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)". 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 routinel...
What is the current status of trial NCT05055830?
This trial is currently recruiting. The enrollment target is 2,000 participants. The study started on 2021-10-05. Estimated completion is 2028-10-30.
What conditions does trial NCT05055830 study?
This clinical trial studies the following conditions: Cardiac Disease, Critically Ill, Children, Adult.
What interventions are being tested in trial NCT05055830?
The interventions under investigation include: The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care. (DRUG).
Who is sponsoring clinical trial NCT05055830?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05055830 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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