External Validation Study of a Laboratory-based Perioperative Prediction Model for Acute Kidney Injury After Cardiac Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- - Confirm the usefulness and externally validate the Demijirian scale.
研究概览
简要总结
To predict the renal damage caused by cardiac surgery in patients to try to mitigate it as soon as possible
详细描述
Acute Kidney Injury (AKI) is a major complication of cardiac surgery and its most severe forms are associated with significant morbidity and mortality .
Identification of patients at risk may facilitate early use of management protocoolos recommended by KDIGO (Kidney Disease: Improving Global Outcomes), such as haemodynamic and volume optimisation, monitoring of renal function and discontinuation or reduction of nephrotoxic drugs . The rate associated with cardiac surgery varies according to its different historical definitions, from 0.3% to 29.7% . Cases requiring renal replacement therapy (RRT) occur between 1 .2%-3.0% in the studied cardiac surgery cohorts and their presence is a n independent predictor of mortality.
Because AKI still lacks effective treatments in addition to support and elimination of the cause, early and specific diagnosis is an unmet but critical need f o r successful and personalised patient management.
Creatinine, urea and urine output have been and are the main ways to diagnose and treat renal failure. Other types of biomarkers that seem to be related to risk of postoperative AKI are currently under study. Although more research is needed, they may eventually become predictive diagnostic tools. Several studies have indicated that the urinary level of NGAL excreted intraoperatively and after surgery is effective in predicting AKI in both adult and paediatric populations. Similar results have been obtained with other urinary biomarkers, such as the cell cycle arrest biomarkers TIMP-2 and IGFBP7) KIM-1, NAG, IL-18 and L-FAP . The major limitation of these biomarkers is that they are not easily accessible in all hospitals and clinical settings. Recently Demirjian developed a predictive model in which they observed that perioperative change in serum creatinine and postoperative blood urea nitrogen, serum sodium, potassium, bicarbonate and albumin from the first metabolic panel after cardiac surgery show good predictive value for moderate to severe AKI within 72 hours and 14 days after the surgical procedure.
3. Hypothesis
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
- 是
入选标准
- •All patients over 18 years of age undergoing cardiac surgery.
排除标准
- •Exitus in the first 48h postoperative period
- •Patient undergoing renal replacement therapy or preoperative dialysis
- •Minor" cardiac surgery ( sternal dehiscence, MCP removal or implantation, pericardial window)
结局指标
主要结局
- Confirm the usefulness and externally validate the Demijirian scale.
时间窗: up to 14th postoperative day
Validate scale
- Compare this scale with other models of AKI prediction after cardiac surgery: Thakar, Mehta, ISR, Callejas, Leicester, CRATE.
时间窗: up to 14th postoperative day
Score validation
次要结局
- - Identify new risk factors for Acute Kidney Injury (AKI)(from surgery to 4months postoperative)
- - Validating a model for predicting discharge dialysis after cardiac surgery(from surgery to 4monts postoperative)
- risk factors for new Chronic Kidney Disease (CKD)(from surgery to 4months postoperative)
- Drugs related with CSA AKI(from surgery to 4months postoperative)
研究者
Luis Baeza Álvarez
Principal Investigator
Universidad de Oviedo