Hyperoxia During Cardiopulmonary Bypass in Adult Cardiac Surgery: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Number of of kidney failure in adult patients undergoing to elective cardiac surgery required CPB
研究概览
简要总结
This single-center randomized controlled pilot trial evaluates the effects of intraoperative hyperoxia compared with normoxia during cardiopulmonary bypass (CPB) in adult patients undergoing elective cardiac surgery. The primary aim is to assess the impact on postoperative renal function. Secondary outcomes include inflammatory markers, cardiovascular and pulmonary complications, resource utilization, and short-term mortality.
详细描述
This monocentric randomized controlled pilot trial enrolled adult patients undergoing elective cardiac surgery requiring CPB. Participants were randomized (1:1) to receive either normoxic (PaO₂ 70-150 mmHg) or hyperoxic (PaO₂ >300 mmHg) oxygenation strategies intraoperatively.
The study evaluates postoperative renal function using eGFR, NGAL, renal replacement therapy, and KDIGO classification. Secondary outcomes include IL-6 levels, arrhythmias, mechanical circulatory support, surgical complications, ventilation duration, ICU/hospital stay, and 28-day mortality.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients (>18 years old)
- •need for elective cardiac surgery requiring CPB (i.e., isolated valve repair/replacement, coronary artery bypass grafting, or ascending aorta surgery)
- •Time frame from July 1st to September 15th 2025
排除标准
- •refusal of consent,
- •pregnancy,
- •previous Intensive Care Unit (ICU) admission,
- •history of cardiac surgery requiring CPB,
- •signs of preoperative cardiogenic shock (defined as requiring inotropic support, intra-aortic balloon pump, or other mechanical circulatory assistance),
- •intraoperative need for circulatory arrest.
研究组 & 干预措施
Normoxia group
Normoxia group (control): After endotracheal intubation, FiO₂ was initially set to 0.3 and subsequently adjusted to maintain PaO₂ between 70 and 150 mmHg. During CPB, air and oxygen flows through the oxygenator were titrated to maintain a target PaO₂ between 70 and 150 mmHg.
干预措施: Normoxia group (control) (Other)
Hyperoxia group
Hyperoxia group (intervention): After endotracheal intubation, FiO₂ was maintained at 0.8 and subsequently adjusted to achieve PaO₂ above 300 mmHg. During CPB, air and oxygen flows through the oxygenator were titrated to maintain a target PaO₂ greater than 300 mmHg.
干预措施: Hyperoxia group (Other)
结局指标
主要结局
Number of of kidney failure in adult patients undergoing to elective cardiac surgery required CPB
时间窗: At 24 hours after surgery
The renal outcomes were evaluated 24 hours after surgery, on the first postoperative day. The failure was defined according to KDIGO criteria and included estimated glomerular filtration rate (eGFR), serum Neutrophil Gelatinase-Associated Lipocalin (NGAL), and the need for postoperative renal replacement therapy.
次要结局
- Number of patients experienced surgical complications(within 28 days after randomization)
- Number of patients with NGAL > 50ng/ml (index of acute kidney injury)(At 24 hours after surgery)
- Number of renal replacement therapy after surgey(Within 24 hours postoperatively)
- Number of patients affected by postoperative arrhythmias(within 28 days after randomization)
- Number of patients needing extracorporeal membrane support(within 28 days after randomization)
- Number of patients needing tracheostomy(within 28 days after randomization)
研究者
Annalisa Boscolo
Prof
University of Padova