NCT03037281已完成不适用
Does the Release Profile of Nociceptin From Immunocytes Differ in Healthy Volunteers and Critically Ill Patients With Sepsis?
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Proportion of Responsive Biosensor Cells Responding to Granulocyte Addition in the Presence and Absence of NOP Antagonist
研究概览
简要总结
Nociceptin is a protein found in the body, with a number of functions in the central nervous system, blood vessels and the gut. There is evidence that it may have a role in controlling the immune response to infection, and may act as a link between the brain and immune system.
In infection, or after surgery, there is an increase in nociceptin, and subjects greater elevations of nociceptin have a poorer outcome. There is evidence that cells of the immune system may produce nociceptin, although it is not yet known which cells are capable of producing it, and what "switches on" production.
This study aims to determine
- Which cells of the immune system can produce nociceptin
- If there is a difference in the ability to produce nociceptin between healthy volunteers and patients with severe infections
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For septic patients;
- •Participant is willing and able to give informed consent for participation in the study, or if lacking capacity, a next of kin or advocate is willing and able to give assent for participation in the study. Must be able to read and understand English.
- •Male or Female, aged 18 years or above.
- •Diagnosed with sepsis and admitted to the intensive care unit.
- •Able (in the Investigators opinion) and willing to comply with all study requirements.
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
- •Healthy Volunteers;
- •Participant is willing and able to give informed consent for participation in the study. Must be able to read and understand English.
- •Male or Female, aged 18 years or above and be
- •In good health.
- •Have had no course of medication, whether prescribed or over-the-counter, in the four weeks before first study dose and no individual doses in the final two weeks other than mild analgesia, vitamins and mineral supplements or, for females, oral contraceptives
- •Able (in the Investigators opinion) and willing to comply with all study requirements.
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
排除标准
- •Conditions which may make phlebotomy hazardous to the participant (such as significant bleeding disorders or anaemia, or allergy), or to the investigator (blood viral infection).
- •Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- •Participants who have participated in another research study involving an investigational product in the past 12 weeks.
结局指标
主要结局
Proportion of Responsive Biosensor Cells Responding to Granulocyte Addition in the Presence and Absence of NOP Antagonist
时间窗: Day 1
Measure of N/OFQ presence in granulocytes and associated supernatant
次要结局
- Acute Physiology and Chronic Health Evaluation (APACHE-2) Score(Day 1)
- Sequential Organ Failure Assessment (SOFA) Score(Day 1)
- Granulocyte Count(Day 1)
- Mortality In-hospital, at 30 Days(30 days)
- Time to ICU Discharge (or Death if on ICU)(Time to ICU discharge (or death if on ICU))
- Time to Death or Discharge(Number of days between admission and death or discharge from hospital)
研究者
研究点 (2)
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