Clinically Integrated Opportunistic PK/PD Trial in Critically Ill Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Months 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •1. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
研究组 & 干预措施
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
干预措施: The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care. (Drug)
结局指标
主要结局
Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling
时间窗: Data will be collected up to 180 days from the time of consent
Half-life (t1/2) as measured by PK sampling
时间窗: 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
时间窗: Data will be collected up to 180 days from the time of consent
AUC (area under the curve) as measured by PK sampling
时间窗: Data will be collected up to 180 days from the time of consent
次要结局
未报告次要终点