Blood Sampling Pre- and Post-Propofol to Characterize the Blood Proteome Using Different Research Assays
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The primary endpoint of this study is the reproducibility measurements based on the repeated quantifications of biomarkers using different biomarkers assays pre- and post-propofol.
研究概览
简要总结
Background:
Propofol is a drug that helps people fall asleep quickly and stay asleep during surgery, so they do not feel any pain. This drug is also used to sedate critically ill people who must be on a ventilator (a machine to help them breathe). To better understand how to interpret blood tests in these ill people, researchers need to know more about how the drug itself may change proteins in the blood.
Objective:
To collect blood samples from people before and after propofol is administered for surgery.
Eligibility:
People aged 18 years or older who are scheduled for surgery that requires sedation with propofol.
Design:
Participants will have data collected. This data will include age, sex, and ethnicity. They will be asked about their medical history.
Participants will have blood samples collected before and after they receive propofol for their surgery. The blood will be collected from lines already installed for the surgery; no new needlesticks will be done for the study. A total of 3 teaspoons of blood will be drawn.
The samples will be compared to each other to look for any changes caused by the drug.
No follow-up visits are required.
详细描述
Study Description:
This is a blood procurement research protocol. The study will collect a total of 3 blood samples at 2 timepoints (1 blood sample prior to propofol and 2 after propofol dosing) from up to 10 participants pre- and post-induction of anesthesia with propofol to characterize the effects of propofol on the measurement of the blood proteome using different research assays. Blood samples will be withdrawn from existing intravenous access so that no additional interventions are required. The PI, or team designee, will have a discussion with the primary surgeon to determine suitability of the potential participant for eligibility. If determined suitable, the participant will be recruited by invitation. All potential participants will be consented to a primary surgical protocol; consent to this protocol will be secondary and obtained prior to the procedure.
Objectives:
Primary Objective:
The primary objective of this research protocol is to procure blood samples from participants prior to and post propofol administration to quantify the impact of propofol on the quantification of the blood proteome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision of signed and dated informed consent form
- •Participant consented for a surgical procedure (primary surgical protocol) anticipated to require induction with propofol.
- •Male or female aged 18 years or older.
- •Ability of subject to understand and the willingness to sign a written informed consent document.
排除标准
- •Surgical procedure not utilizing propofol
- •Hemoglobin < 7 ug/dL at the time of enrollment
- •Inability to sign consent
研究组 & 干预措施
Critically ill surgical patients
Participant consented for a surgical procedure (primary surgical protocol) anticipated to require induction with propofol.
结局指标
主要结局
The primary endpoint of this study is the reproducibility measurements based on the repeated quantifications of biomarkers using different biomarkers assays pre- and post-propofol.
时间窗: 1 year
The investigators would like to use the O-link Explore HT and SomaScan Discovery v4.1assay on samples from participants who are critically ill. In order to do this understanding, the impact of propofol on each analyte must be understood as there is potential for interference with propofol in each sample.
次要结局
未报告次要终点