Postoperative Infections and Immune Profiles in Patients Undergoing LVAD Implantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- culture-proven infections
研究概览
简要总结
The objective of this study is to investigate the incidence of infection and changes in the immune profile following left ventricular assist device implantation. The primary aim is to elucidate the relationship between postoperative infection and immune alterations and to identify risk factors predictive of postoperative infection.
详细描述
- Background: left ventricular assist devices (LVADs) implantation is an important treatment for end-stage heart failure. Previous studies have indicated that implantation of a left ventricular assist device may alter a patient's immune status by affecting immune cells, which may be a significant reason for the high postoperative infection rate among patients. Previous studies have indicated that left ventricular assist device implantation may alter patients' immune status by affecting immune cells, which may be a significant factor contributing to high postoperative infection rates. The aim of this study is to evaluate infection events following LVAD implantation and their relationship with patients' immune status. this will be crucial for predicting infection occurrence and identifying potential intervention strategies.
- Study design:
Design Type: Retrospective, observational, multi-center study Study Population: patients who received LVAD implantations between June 2020 and October 2025 at 2 centers in China.
Primary Objective: To evaluate the incidence of infection rate after LVAD implantation .
Secondary Objectives: To identify factors associated with infection, assess the immune status alteration after LVAD implantation. 3. Study Population Inclusion criteria (i) age >18 years, (ii) indication for LVAD implantation, (iii)informed consent.
Exclusive criteria included active preoperative infection and no other circulatory support devices were used preoperatively
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •(i) age >18 years, (ii) indication for LVAD implantation, (iii)informed consent.
排除标准
- •(i) active preoperative infection (ii) other circulatory support devices were used preoperatively
结局指标
主要结局
culture-proven infections
时间窗: Infection confirmed within 90 days postoperatively is defined as early infection; infection confirmed after 90 days postoperatively is defined as late infection.
次要结局
- immune parameters changes after LVAD implantation.(Blood test results available at various follow-up intervals from preoperative to postoperative periods, including 2 weeks, 1 month, 3 months, 6 months, etc.)