Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Renal oxygen delivery and blood flow
研究概览
简要总结
During open cardiac surgery, cardiopulmonary bypass (CPB) is used to temporarily replace the function of the heart and lungs. Renal ischemia resulting in acute kidney injury is common after cardiac surgery. The renal oxygenation is impaired during CPB, but the oxygenation may be improved by increasing the CPB blood flow. In this randomized study, two CPB flow rates will be compared regarding renal outcome (biomarkers and renal oxygenation/renal blood flow), as well as markers of inflammation and hemolysis. Additionally, urine oxygen tension will be measured during CPB and the early intensive care phase and compared to renal oxygenation. Regional oxygen saturation assessed with near infrared spectroscopy from the brain and kidneys will be monitored during and after surgery.
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
- •Written, signed informed consent
- •Male and female subjects ≥18 years
- •Left ventricular ejection fraction ≥30 %
- •Estimated GFR ≥30 ml/min using the CKD-EPI equation (Levey 2009)
- •Scheduled open cardiac surgery with CPB
- •Planned normothermia during CPB
- •Expected CPB time > 60 minutes
排除标准
- •Emergency surgery
- •Cardiac transplantation
- •Advanced grown-up congenital heart disease corrections
- •Previous cerebral infarction, verified with computed tomography or magnetic resonance imaging
- •Body mass index > 32 kg/m2
- •Use of hypothermia < 32 °C during CPB
- •Inability of the patient to give based opinion
- •In the investigator´s opinion, the patient has a condition that could be adversely affected by study participation
结局指标
主要结局
Renal oxygen delivery and blood flow
时间窗: 6 hours
Renal oxygen delivery during and after cardiopulmonary bypass (CPB)
Biomarkers Nephrocheck
时间窗: 24 hours
Renal biomarker assay Nephrocheck (IGFBP-7 x TIMP-2) will be analyzed in urine
Biomarker u-NAG
时间窗: 24 hours
Tubulus injury biomarker N-acetyl-ß-d-glucoseaminidase (NAG) will be analyzed in urine with a spectrophotometric method and corrected for urine creatinine.
次要结局
- Serum creatinine and acute kidney injury (AKI)(48 hours)
- Inflammation IL-8(24 hours)
- Inflammation TNFa(24 hours)
- Inflammation IL-10(24 hours)
- Inflammation IL-1(24 hours)
- Inflammation IL-6(24 hours)
- Hemolysis(24 hours)
- Erythropoetin(24 hours)
- Neuroinflammation NF(4 days)
- Complement activation(24 hours)
- Kidney function(24 hours)
- Neuroinflammation Tau(4 days)
- Renal function(24 hours)
研究者
Lukas Lannemyr
Specialist of Anesthesia and Intensive care
Sahlgrenska University Hospital, Sweden