Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function.
研究概览
简要总结
To test the hypothesis that leukocyte filtering during cardiopulmonary bypass (CPB) might reduce the inflammatory response and protect the lungs against the acute injury
详细描述
BACKGROUND AND OBJECTIVES: The extension of the systemic inflammatory response observed after cardiopulmonary bypass (CPB) in cardiac surgery is associated to postoperative pulmonary dysfunction degree. The leukocyte depletion during CPB can modify that response. The aim of this study was to evaluate the effects of leukocyte filtering on the inflammatory response and lung function in patients undergoing coronary artery bypass grafting.
METHODS: After approval by the institutional ethical committee, a prospective randomized study was performed to compare nine patients undergoing coronary artery bypass grafting (CABG) using leukocyte filtration in the arterial line (LG-6, Pall Biomedical Products) and eleven others submitted to standard CPB. Chest CT, oxygenation analysis and a complete leucocyte count were performed before surgery. After intravenous anesthesia induction, patients were mechanically ventilated with tidal volume of 8 mL.kg-1, with FiO2 0.6, and PEEP of 5 cm H2O, except during CPB. Haemodynamic data, PaO2/FiO2, shunt fraction, interleukins, elastase and myeloperoxidase were evaluated before and after CPB, at the end of surgery, 6, 12 and 24 hours after surgery. Chest CT was repeated on the first postoperative day. Data were analyzed using two-factor ANOVA for repeated measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing coronary artery bypass grafting (CABG), having their physical state classified as PII and PIII, according to the American Society of Anesthesiologists (ASA). Surgical risk was stratified according to Parsonnet criteria, and only patients considered low to moderate risk were admitted.
排除标准
- •Subjects older than 70 years
- •Body mass index (BMI) over 35 kg/m2
- •Congestive heart failure (CHF) greater than class III (NYHA)
- •Left ventricle ejection fraction less than 40%
- •Submitted to recent surgery
- •creatinine ≥ 1.4 mg / dL or in use of oral anticoagulants were excluded
结局指标
主要结局
Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function.
时间窗: 24 hours
The primary outcome was the evaluation of the effects of leukocyte filtration on lung function in patients undergoing coronary surgery.
次要结局
- Evaluation of the effects of leukocyte filtration on the inflammatory response in patients undergoing coronary surgery.(24 hours)
研究者
Maria José Carvalho Carmona
Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function
University of Sao Paulo