Correlation of Brain and Thenar Muscle Oximetry During Cardiac Surgery With Parameters of Acute Kidney Injury in Adult Cardiac Surgical Patients Operated on Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- NGAL
研究概览
简要总结
Identification of risk factors of acute kidney injury (AKI). It is hypothesized that there might be a correlation between brain oximetry, tissue saturation of thenar muscle and marker of AKI in blood - neutrophil gelatinase-associated lipocalin (NGAL) - measured in blood samples during the first post-op day.
详细描述
The day before operation, after verification of inclusion and exclusion criteria, the visiting anesthesiologist will explain to the patient the aim of the study. By signing an informed consent the patient will be recruited into the study. On the evening before operation the patient will receive the statin in a dose taken along.
In the OR the anesthesiologist will verify if creatinin and blood urea nitrogen were measured the day before operation - if not, a blood sample for the test will be obtained and sent to perform the tests.
Before induction of anesthesia a bi-spectral index (BIS) probe will be placed on the patients forehead. Above the BIS probe a INVOS(TM) probe for brain oximetry (5100 C Cerebral/Somatic Oximeter, Somanetics, Medtronic) will be placed.
Brain oximetry by near infrared saturation (NIRS) and tissue saturation on thenar muscle will be recorded before and during operation on nine timepoints.
As NIRS and thenar muscle saturation are non-routine non-invasive methods of intraoperative monitoring, patient had to sign an informed consent to participate into the study, and ethic committee approval for the study protocol was appealed and granted.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult patients
- •signed informed consent
- •scheduled for elective on-bypass cardiac surgery (aortic valve surgery, mitral valve surgery with/without tricuspid valve surgery, ascending aorta surgery with/without aortic valve surgery).
排除标准
- •chronic kidney insufficiency (serum creatinine >2 mg/dL)
- •active infection (i.e.: endocarditis)
- •shock or tissue hypoperfusion before operation (blood lactate >3 mmol/L)
- •left ventricle ejection fraction <25%
- •vancomycin used for infection prophylaxis (i.e.: in immunosuppressed patients)
- •history of ischaemic shock
结局指标
主要结局
NGAL
时间窗: 3 hours after operation
neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples
次要结局
- NGAL on second day(second post-op day morning)
- Cystatin C(second post-op day morning)
- Serum creatinine(second post-op day morning)
- Acute renal failure(30 day / any time after operation before discharge from hospital)
- In hospital mortality(30 day / any time after operation before discharge from hospital)
研究者
Romuald Lango
Dr hab. med. Romuald Lango
Medical University of Gdansk