Urinary Biomarkers for the Prediction of Acute Kidney Injury Following Major Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The diagnostic performance (expressed as the 'Area under the receiver-operator curve') of Urinary Biomarkers for the rapid prediction of Acute Kidney Injury in Major Abdominal Surgery patients.
研究概览
简要总结
To validate Urinary Biomarkers for the prediction of AKI in major abdominal surgery patients
详细描述
Background
Surgery is a risk factor for acute kidney Injury (AKI). Surgery exposes patients to hypotension, sepsis, the infusion of blood products, ischaemia, oxidative stress and reperfusion injury.
Patients who develop AKI post operatively are susceptible to fluid overload, infections, and cardiac events. AKI confers an increased risk of chronic kidney disease and mortality. Studies assessing rates of AKI in general surgical patients place the frequency at 1-14%.
Established methods of assessing for AKI - products of nitrogen breakdown and urine output - have limitations. Serum creatinine and urea are affected by sex, nutritional status, blood in the gastrointestinal tract, and fluid resuscitation. Rises in serum creatinine become apparent once glomerular filtration has reduced by half. This potentially delays the use of reno-protective strategies.
Novel biomarkers have been investigated. These aim to verify the use of renal biomarkers as a method of identifying AKI more rapidly: It is hoped that reno-protective strategies could be adopted sooner.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients aged over 18 undergoing major Hepatobiliary, Oesophagogastric, Colorectal or abdominal Gynaecological Surgery at the Royal Surrey County Hospital. Patients undergoing Liver Transplant Surgery at King's College Hospital
- •Be able to provide informed consent
排除标准
- •Patients requiring renal replacement therapy prior to the study
- •Patients with pre-operative AKI
- •Patients without baseline creatinine measurements
- •Day case surgery
- •Patients unable to consent
结局指标
主要结局
The diagnostic performance (expressed as the 'Area under the receiver-operator curve') of Urinary Biomarkers for the rapid prediction of Acute Kidney Injury in Major Abdominal Surgery patients.
时间窗: The study aims to assess the diagnostic performance of the biomarkers to predict the development of AKI within 3 days of the surgical procedure. Renal function will be assessed daily within this time frame.
Conventional renal function measurement - assessing blood creatinine - often does not identify Acute Kidney Injury until 48 hours has passed from the time of insult. It is hypothesised that the studied urinary biomarkers may be able to identify patients who develop AKI 4 hours post-operatively.
次要结局
未报告次要终点