Preoperative Renal Functional Reserve to Predict Risk of Acute Kidney Injury After Cardiac Surgery: The IRRIV Task Force and Collaborators for the Prevention of Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Whether a reduced preoperative RFR ≤15 ml/min/1.73 m2 increased the odds ratio for postoperative acute kidney injury in patients undergoing elective cardiac surgery.
研究概览
简要总结
The investigators seek to determine whether a reduced preoperative renal functional reserve predicts postoperative acute kidney injury in patients with normal estimated glomerular filtration rates undergoing elective cardiac surgery.
详细描述
Although acute kidney injury (AKI) frequently complicates cardiac surgery, methods to determine AKI risk in patients without underlying kidney disease are lacking. Renal functional reserve (RFR) can be used to measure the capacity of the kidney to increase glomerular filtration rate under conditions of physiological stress and may serve as a functional marker that assesses susceptibility to injury.
The investigators seek to determine whether a reduced preoperative RFR predicts postoperative AKI in patients with normal estimated glomerular filtration rates undergoing elective cardiac surgery. All centres will measure RFR with creatinine clearance, except University Hospital Giessen where in addition iohexol plasma-clearance will be used.
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
- •Subjects older than 18 years
- •Subjects undergoing elective cardiac surgery (with or without cardiopulmonary bypass)
- •Subjects with an estimated GFR ≥60 ml/min/1.73 m2 (CKD-Epidemiology Collaboration equation)
- •Subjects who signed informed consent forms
排除标准
- •Preexisting acute kidney injury (as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)
- •Chronic kidney disease ≥ stage III (KDIGO)
- •Subjects undergoing transcatheter aortic valve implantation (TAVI)
- •Solitary kidney
- •Diabetes mellitus type 1
- •Recent cardiac arrest (within last 3 months)
- •Liver failure or cirrhosis
- •Total parenteral nutrition
- •Hemoglobin <11 g/dl
- •History of malabsorption, chronic inflammatory bowel disease, short bowel, or pancreatic insufficiency
- •Transplant donor or recipient
- •Active autoimmune disease with renal involvement
- •Rhabdomyolysis
- •Prostate hypertrophy with International Prostate Symptom Score ≥20
- •Active neoplasm
- •Decompensated heart failure / inability to pause angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers minimum 2 days before protein load
- •Known iodine allergy (exclusion criteria only for those centres who use iohexol plasma clearance for determination of GFR)
- •TSH <0.3 µU/l (exclusion criteria only for those centres who use iohexol)
- •Subjects who received intravenous radiocontrast agents within the 72 hours before the protein load
- •Subjects who received NSAIDs within 48 hours before the protein load
结局指标
主要结局
Whether a reduced preoperative RFR ≤15 ml/min/1.73 m2 increased the odds ratio for postoperative acute kidney injury in patients undergoing elective cardiac surgery.
时间窗: Preoperative
Renal functional reserve
次要结局
- determine preoperative RFR accuracy based on receiver operating characteristic curve curve to predict acute kidney injury.(Preoperative)
- Mortality at 30 and 90 days(30 and 90 days after surgery)
- To evaluate renal function at three months after surgery.(3 months after surgery)
- Use and duration of renal replacement therapy during hospital stay.(Postoperative)
- Renal replacement therapy dependence at days 30 and 90.(30 and 90 days after surgery)
- To evaluate whether chronic kidney disease is associated to preoperative RFR.(Preoperative)
- To analyze an acute kidney injury risk prediction model based on clinical covariates.(Preoperative)
- Length of stay in intensive care unit and hospital.(Postoperative)
- To evaluate whether preoperative RFR is correlated to renal function at three months after surgery.(Preoperative)
研究者
Faeq Husain-Syed
Senior Physician
University of Giessen