The Impact of Pre-emptive Intraoperative Use of Extracorporeal Cytokine Adsorption During Orthotopic Heart Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Early postoperative hemodynamic instability
研究概览
简要总结
There are several factors initiating cytokine storm and dysregulated systemic inflammatory response during cardiac transplantation. This may lead to serious perioperative complications: circulatory collapse, respiratory insufficiency, acute renal and liver failure, multi-organ dysfunction etc.
On the other hand the high level of cytokines may play an important role in the development of graft rejection which is still a relevant problem in this patient group.
There are some new data showing that the use of extracorporeal cytokine adsorber during long cardiopulmonary bypass time (>120min) may be beneficial to prevent SIRS (Systemic Inflammatory Response Syndrome) with decreasing the level of cytokines in patients undergoing elective cardiac surgery. However there is lack of data and studies regarding the effect of extracorporeal cytokine adsorption during cardiac transplantation.
The aim of the study is to investigate the effect of extracorporeal cytokine adsorber built in the cardiopulmonary bypass circle during heart transplantation. The hypothesis is that removal of cytokines during heart transplantation prevents the development of extreme systemic inflammatory response, hemodynamic collapse dominated by vasoplegia, and contribute to reduce the incidence of severe perioperative complications and early graft rejection.
详细描述
Patients undergoing cardiac transplantation will be enrolled in the study after giving a written, signed informed consent.
The participants will be randomized into two groups:
- intervention group (30 patients): a cytokine adsorber (CytoSorb®) will be installed into the cardiopulmonary bypass circle during the operation
- control group (30 patients): no cytokine adsorber will be used during cardiopulmonary bypass
The investigators will collect demographic, clinical and laboratory data about patients before, during and after the operation.
The the use of vasopressors and inotropes in the perioperative period, length of mechanical ventilation, ICU and hospital stay, and incidence of perioperative complications, early cellular or humoral graft rejection, and survival will be documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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 heart transplantation
- •no medical or mechanical circulatory support straight before transplantation
- •age > 18 years
排除标准
- •age < 18 years
- •septic condition (controlled infection) before transplantation
- •prolonged hospital stay straight before transplantation
- •use of positive inotropes or vasopressors straight before transplantation
- •use of mechanical circulatory support straight before transplantation
- •acute liver or kidney failure straight before transplantation
- •high urgency transplantation
- •retransplantation
- •the patient declines participating in the study
结局指标
主要结局
Early postoperative hemodynamic instability
时间窗: 24-48 hours
Hemodynamic instability described by Vasoactive Inotropic Score and calculated for the first two postoperative days. Vasoactive Inotropic Score is considered as 'high' if values ≥ 30 points, representing higher risk for worse outcomes.
Postoperative vasoplegia syndrome
时间窗: 24-48 hours
Severity of postoperative vasoplegia based on criteria of vasoplegia syndrome: Norepinephrine reqirements ≥ 0.3 μg/kg/min AND arginine vasopressin requirements at any dose
Cytokine and complement levels
时间窗: 24-48 hours
Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-10, IL-17, tumor necrosis factor-alfa) and complements immediately after induction of anesthesia, before initiation of cardiopulmonary bypass (CPB), 2 hours after initiation of CPB, at termination of CPB, 6-12-24 hours after initiation of CPB
次要结局
- Hospital stay(up to 6 months)
- Length of survival(1 year)
- Inflammatory reaction(24-48 hours)
- Mechanical ventilation(up to 6 months)
- Medical circulatory support(72 hours)
- The incidence of early rejection(1 month)
- Perioperative complications(up to 1 month)