Efficacy of Intravenous In-line Filter in Patient Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 486
- 试验地点
- 2
- 主要终点
- Incidence of SIRS after cardiac surgery
研究概览
简要总结
The aim of this study is to demonstrated efficacy of in-line filtration to reduce systemic inflammatory response syndrome (SIRS) ,specific organ dysfunction and complications in adult cardiac surgery. 486 patients undergoing cardiac surgery for acquired heart disease are 1:1 randomized into in-line filtration (study group) and non-filtration (control group). The incidence of SIRS, complications, daily SOFA (sequential organ failure assessment) score are compared between groups.
详细描述
This clinical trial is performed at Ramathibodi hospital, Mahidol university in Bangkok, Thailand. The protocol has been approved by institutional ethical committee (ref. ID 11-60-64) with informed consent required for all patients.
The incidences of SIRS between the control and the filter group in pediatrics population from previous study were 35% and 25.2% respectively (risk difference -11.3%, 95% CI -21.8 to -0.5%). The author estimated the sample size of 486 randomized patients to give 80% power at the 10% significant level (alpha 0.1, beta 0.8).
Patients aged 18 years or older undergoing elective cardiac surgery for acquired heart disease (including isolated coronary artery bypass grafting (CABG), isolated valve surgery, combined valve surgery, or concomitant CABG and valve surgery) are randomized 1:1 into in-line filtration (study group) and non-filtration (control group).
For patients randomized to in-line filtration, in-line filters (Pall, Dreieich, Germany) are used for all intravenous access during operation and postoperative period in intensive care unit (ICU).
For patients randomized to control group, All intravenous access is managed routinely according to local standard care without filtration during operation and postoperative period in ICU.
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
- Double (Care Provider, Investigator)
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 age 18 years or older undergoing elective adult cardiac surgery
排除标准
- •Emergency surgery
- •Patient who does not want to participate in the study
结局指标
主要结局
Incidence of SIRS after cardiac surgery
时间窗: SIRS is evaluated every 24 hours from immediate post-op to 96 hours postoperatively
SIRS is diagnosed when patients have two or more of these criteria: 1.Heart rate \>90/min, 2.Temperature \>38 °C or \<36 °C, 3.Respiratory rate \>20/min or Paco2 \<32 mm Hg (4.3 kPa), and 4.White blood cell count \>12000/mm3 or \<4000/mm3 or \>10% immature band.
次要结局
- Daily SOFA score(SOFA score is evaluated every 24 hours from immediate post-op to 96 hours postoperatively)
- Incidence of Operative mortality(up to 1 month postoperatively)
- Incidence of Renal Failure(up to 1 month postoperatively)
- Incidence of Major Morbidity or Operative Mortality(up to 1 month postoperatively)
- Incidence of Prolonged Ventilation > 24 hours(up to 1 month postoperatively)
- Incidence of Deep sternal wound infection(up to 1 month postoperatively)
- Incidence of Permanent Stroke(up to 1 month postoperatively)
- Incidence of Reoperation for any reason(up to 1 month postoperatively)