Is Pre-operative Impaired imMune rEsponsiveness Associated With Adverse Outcome Following Aortic Valve Replacement SURgEry (MEASURE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of participants who develop any post operative, healthcare associated infection.
研究概览
简要总结
There is considerable morbidity and mortality associated with cardiac surgery. Currently little effort is made to quantify how well the immune system of an individual can cope with inflammation or infection to which they are exposed during surgery.
The investigators have previously demonstrated that having higher pre-operative antibody levels is associated with a lower risk of infection and a shorter stay in hospital after cardiac surgery.
The investigators aim to study 150 patients undergoing aortic valve replacement and explore their dynamic immune responsiveness. The investigators will determine if this response is correlated with the post-operative outcome (development of post-operative infection or increased length of hospital stay).
The investigators will compare this response with the previously measured static markers of immune competence and also with a novel device that may give a more rapid measure of dynamic immunity.
The investigators will approach patients in the cardiac surgical pre-assessment clinic to see if they are willing to participate in the study.
Immediately once under anaesthetic blood will be taken for testing and then again at the end of surgery, 24h after surgery, at discharge from hospital, and at follow-up clinic approximately 4 weeks later. There will be no additional needle insertions on top of those routinely performed. The investigators will collect data from the routine observations as far as 1 year after surgery.
If the investigators can show an association between immune function and subsequent post-operative outcome it may be possible to determine ways to improve outcomes for patients undergoing heart surgery.
This might include better information on risks and benefits of surgery, actively boosting immune function (vaccination, immune-nutrition), passively improving immunity (administering antibodies), or consider current alternatives to open heart surgery where the threat of infection or inflammation may be markedly reduced (eg trans-catheter aortic valve implantation)
详细描述
Experimental design and methods:
Setting:
Barts Heart Centre is a 255-bedded specialist cardiac centre where approximately 200 primary isolated open aortic valve replacement procedures are performed per year. It is closely associated both geographically and academically with the William Harvey Research Institute (WHRI), which forms part of Queen Mary University, London (QMUL). This will allow laboratory analysis of all collected blood samples within 15 minutes if necessary. Barts Heart Centre is one of the largest cardiac units in Europe and a key research objective of QMUL/WHRI is to support cardiac research.
Sample collection and storage:
Following written informed consent all patients will be pre-operatively risk-scored by means of ASA, Euroscore 2 and conventionally risk-scored for the development of surgical site infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Patients undergoing first-time open aortic valve replacement surgery
排除标准
- •Age less than 18y (capacity to consent)
- •Ongoing sepsis (immunomodulatory effects, established influence on outcome from surgery)
- •Immunosuppressive therapy
- •Suffering from known immunosuppressive disease
- •Pregnancy (immunosuppressive aspects to pregnancy)
结局指标
主要结局
Number of participants who develop any post operative, healthcare associated infection.
时间窗: Development of a HealthCare Associated Infection (HCAI) will be evaluated at one year from date of discharge from hospital.
Development of post-operative healthcare associated infection as defined in the Centre for Disease Control and National Healthcare Safety Network guidance.
次要结局
- Does the result from a simple, point of care test of immune function correlate with that from a more comprehensive, laboratory based test of immune function(2 years)
- Correlation of pre-operative antibody levels with in vitro immune response profiles(2 years)
- Post-operative length of stay(Will be assessed at study completion, at one year following discharge from hospital.)