Comprehensive Assessments of Intraoperative NGAL Level in Geriatric Patients Undergoing Laparotomy'
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- the roles of plasma NGAL levels in acute renal failure.
研究概览
简要总结
The aim of this study is to detect early renal dysfunction that may occur during the surgical procedure in geriatric patients who will undergo laparotomy surgery.
In elderly patients undergoing surgery, accurate estimation of organ function is often not possible. Accurate measurement of kidney function is vital to the routine care of patients. Determining kidney function status can predict the progression of kidney disease and prevent toxic drug levels in the body.The biochemical marker creatinine, found in serum and urine, is widely used in the estimation of GFR. Although glomerular filtration rate decreases with aging, creatinine also decreases in the elderly due to muscle loss. Even moderately elevated blood creatinine may be indicative of severe kidney failure. Creatinine clearance (CrCl) is the volume of blood plasma cleared of creatinine per unit time. It is a fast and cost-effective method for measuring kidney function. Creatine is a breakdown product of creatine phosphate found in skeletal muscle. Its production in the body depends on muscle mass. The CrCl ratio approximates the GFR calculation as it freely filters the glomerular creatine.
High serum creatinine levels and decreased CrCl ratio are usually indicators of abnormal kidney function.One of the markers of acute kidney injury is to look at plasma NGAL values. Plasma NGAL (neutrophil gelatinase associated lipocalin) increases in response to damaged kidney status and can predict acute kidney injury as an early marker. Data on investigating plasma NGAL values as a predictive biomarker of acute kidney injury in patients undergoing non-cardiovascular surgery are very limited NGAL is produced from the epithelium of kidneys, lungs, colon, liver, adipose tissue, and inflammatory cells. NGAL is elevated in serum and urine after acute tubular injury, making it possible to diagnose kidney damage within 2 hours of injury. However, the increase of other traditional markers such as creatinine may be delayed for up to 48 hours after acute kidney injury.To determine the roles of primary outcome serum creatinine, creatinine clearance rates and plasma NGAL levels in the diagnosis of acute renal failure
详细描述
This study will be performed on 60 patients aged 64 years and older who will undergo major abdominal laparotomy surgery in Marmara University Pendik E.A.H Operating Room, whose informed consent forms have been obtained from the patients. Patients with severe cardiac and respiratory distress, liver and kidney failure, and those who did not consent to the study will not be accepted into the study.
Preoperative (0.hour baseline), postoperative 24.,48. BUN, Creatinine, Lactate values in the blood of the patients at 1 hour, and for plasma NGAL, blood samples will be taken at the preoperative, postoperative 6th and 24th hours. And the results will be recorded.
No group will be formed in the study, which includes a total of 60 patients. All patients will be anesthetized by induction of anesthesia (2 mg/kg propfol/ 1-2 mcgr/kg remifentanil/ 0.6 mg/kg rocuronium), and intraoperative inhaler Desflurane + intravenous Remifentanil will be used to provide maintenance anesthesia. Patients will be given intravenous fluids of 4-8 ml/kg/hr with PVI monitoring, if necessary, without fluid restriction.
Statistically is acceptable for the area under the ROC curve to be above 0.700. It has been determined that we need a minimum of 60 people in order to show that an area with a minimum level of 0.700 is statistically significant.
the aim of our study is to detect early renal dysfunction that may occur during the surgical procedure in geriatric patients who will undergo laparotomy surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 64 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 64 years and older (ASA I-II-III class), who were to undergo major abdominal laparotomy surgery, whose consent forms were obtained, were included in the study.
排除标准
- •Patients with severe cardiac and respiratory distress, liver and kidney failure, and those who did not consent to the study will not be accepted into the study.
结局指标
主要结局
the roles of plasma NGAL levels in acute renal failure.
时间窗: first 24 hours after surgery
roles of plasma NGAL levels in the diagnosis of acute renal failure.
次要结局
未报告次要终点
研究者
Meliha Orhon
assistant professor
Marmara University