The Efficacy of Early Postoperative Enteral Immunonutrition on Immune Response and Outcomes in Low-Risk Cardiac Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- CD4+ T cell
研究概览
简要总结
The aim of this study is to investigate the efficacy of early postoperative enteral immunonutrition on immune response and outcomes in the low operative risk cardiac surgery population with low phase angle value measured by the bioelectrical impedance analysis.
详细描述
Study enrolls a low operative risk cardiac surgery patients who undergo elective cardiac surgery with cardiopulmonary bypass (CPB). Patient is offered to take part in a study a day prior to surgery. Information is provided regarding protocol, aim and course of study. Only signing the consent form patients could be enrolled to the study.
Study consists of:
Primary assessment - information about study. Consent form. Assessment of patient according to predefined criteria. Phase angle evaluation by bioelectrical impedance. (Day prior to surgery). It is a specific cohort of patients basically governed by surgery risk and the status of patients' cells. Euroscore II value was used to evaluate the risk of surgery. Bioelectrical impedance analysis derived phase angle was used to evaluate patients' cells frailty and vitality.
First phase of blood sampling - blood samples were taken for evaluation immunological status (cellular and humoral) and inflammatory response (CRB, complete blood count) at the surgery day morning prior to surgery.
Surgery - evaluating the course of the surgery (see exclusion criteria). Randomization - the patients will randomly selected into intervention and control groups. The patients, physicians and investigators were separate from this process. The selection sequence was computer-generated and provided to the researchers by the statistician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Elective cardiac surgery with cardiopulmonary bypass:
- •coronary artery bypass grafting surgery (CABG);
- •aortic valve replacement;
- •mitral valve replacement;
- •mitral valve repair;
- •tricuspid valve repair;
- •combined operations (CABG and valve surgery);
- •Phase angle <5.5⁰ (phase angle was evaluated one day prior to surgery using bioelectrical impedance analysis (InbodyS10 device).
排除标准
- •Preoperative:
- •previous cardiac surgery;
- •left ventricle ejection fraction <40%;
- •use of preoperative intra-aortic balloon pump (IABP);
- •critical preoperative state;
- •pulmonary artery mean pressure >55 mmHg;
- •diagnosis of infectious endocarditis;
- •pacemaker;
- •complicated intraoperative course (unplanned intervention or low cardiac output syndrome in the operating theatre: failure to wean from cardiopulmonary bypass (CPB) or intraoperative insertion of IABP or infusion of two or more inotropic medications with a cumulative dose of 0.2 mcg/kg/min);
- •surgery time >6 h;
- •unplanned intervention;
- •Postoperative:
- •disturbance of dietary rules.
结局指标
主要结局
CD4+ T cell
时间窗: Six days
Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for CD4+ T cells.
CD8+ T cell
时间窗: Six days
Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for CD8+ T cells.
CD69+ T cell
时间窗: Six days
Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for CD69+ T cells.
Interleukin-1 (IL-1)
时间窗: Six days
Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for IL-1.
Interleukin-6 (IL-6)
时间窗: Six days
Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for IL-6.
Tumor necrosis factor alfa (TNFα)
时间窗: Six days
Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for TNFα.
次要结局
- Acute kidney injury(28 days)
- Stroke(28 days)
- ICU infectious complications(28 days)
- Duration of mechanical ventilation(28 days)
- Retoracotomy rate(28 days)
- Mortality(2 years)
- Duration of hospital stay(28 days)
- Rate of rehospitalization(2 years)
研究者
Donata Ringaitiene
PhD Vilnius University Institute of Clinical Medicine Clinic of Anaesthesiology and Intensive Care
Vilnius University