Association of Intraoperative Cerebral and Somatic Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Adult Patients Undergoing Double Valves Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Postoperative acute kidney injury (AKI)
研究概览
简要总结
To investigate the relationship of tissue oxygenation of different organs and tissue beds (e.g., a tissue bed on the arm vs. leg vs. flank tissue bed(s) and renal tissue bed, and thus can be used as a surrogate of renal tissue oxygenation monitoring.
详细描述
In this study, we will monitor tissue oxygenation of four different tissue beds including cerebral tissue (SctO2) on the forehead, and 3 somatic tissue beds monitored on the forearm (SarmO2), upper leg (SlegO2), and the renal region (SrrO2). The primary end point is AKI and the secondary end points are postoperative major non-renal complications (e.g. stroke, delirium, myocardial infraction, heart failure, new or worsening arrhythmia, mechanical ventilation > 24 hours, deep wound infection, etc.) and mortality. The associations between tissue oxygenation of different tissue beds, i.e. SctO2, SarmO2, SlegO2, and SrrO2, and AKI and non-renal outcomes will be compared to explore the tissue bed(s) whose oxygen saturation has a stronger association with the outcomes of interest. The strength of this study is to use the patient as self-control.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained
- •Age ≥18 years of age
- •Double valves replacement surgery with cardiopulmonary bypass (CPB)
排除标准
- •The Trauma, deformity or abnormality sites which the sensor will be put may affect the monitoring of the data
- •Preoperative renal dysfunction needs renal replacement therapy
- •Emergency surgery
- •Preoperative intubated patient
- •Unable to cooperate with the study, i.e., mental illness, et al
- •Patients with hemoglobin and anemia
- •Participate in other trials in the prior 3 months
- •Patient refuses to participate in the study
- •Patient is unfit for the study decided by reach stuff
结局指标
主要结局
Postoperative acute kidney injury (AKI)
时间窗: Seven days postoperatively
AKI is defined as any of the following (Not Graded): * K Increase in serum creatinine (SCr) by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or * K Increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or * K Urine volume o0.5 ml/kg/h for 6 hours.AKI is defined as any of the following (Not Graded): * K Increase in SCr by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or * K Increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or * K Urine volume o0.5 ml/kg/h for 6 hours. AKI is defined as any of the following (Not graded):Increase in SCr by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or urine volume less than 0.5 ml/kg/h for 6 hours.
次要结局
- Length of ICU stay(Postoperative day 0-day 7)
- Length of mechanical ventilation(Postoperative day 0-day 7)
- Length of hospital stay(Postoperative day 0-day 30)
- Adverse events in 30 days(Postoperative day 0-day 30)
研究者
chonglei
M.D.& Ph.D.
Xijing Hospital