Effects of Preoperative High Oral Protein Load on Short- and Long-term Renal Outcomes Following Cardiac Surgery - a Matched Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 主要终点
- Occurrence of AKI after cardiac surgery
研究概览
简要总结
Acute kidney injury (AKI) occurs in approximately one-third of patients undergoing cardiac surgery (CS), and represents one of the most significant negative predictors of patient outcome in this population. In the healthy adult, a high protein meal is known to enhance glomerular filtration rate and is mediated by an increase in renal blood flow. The investigators hypothesized that preoperative oral protein load may precondition the kidneys for upcoming insults and reduce the rate of postoperative AKI and long-term renal outcome.
详细描述
Acute kidney injury (AKI) occurs in approximately one-third of patients undergoing cardiac surgery (CS), and represents one of the most significant negative predictors of patient outcome in this population. To date, there is no therapy to prevent AKI. In the healthy adult, a high protein meal is known to enhance glomerular filtration rate (GFR) and is mediated by an increase in renal blood flow. The investigators hypothesized that preoperative oral protein load may induce an adaptive response of the kidneys, and precondition the kidneys for upcoming insults. In the present study, the investigators aimed to compare the prevalence and severity of AKI in patients undergoing oral high protein load of the 'Preoperative Renal Functional Reserve Predict Risk of AKI after Cardiac Operation' study to age- and gender-matched "controls" who had a standard preoperative care the day prior to surgery within the same period (November 2014-October 2015) at San Bortolo Hospital, Vicenza, Italy. Both groups were followed 1 year post-discharge to evaluate long-term renal outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects older than 18 years undergoing elective cardiac surgery
- •Subjects older than 18 years with an estimated eGFR >60 ml/min/1.73 m2 (CKD-EPI)
- •Subjects who signed informed consent forms
排除标准
- •Chronic kidney disease ≥ stage III (KDIGO criteria)
- •Preexisting acute kidney injury (as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)
- •Solitary kidney
- •Diabetes mellitus type 1
- •Recent cardiac arrest or myocardial infarction up to 7 days before surgery
- •Liver failure or cirrhosis
- •Total parenteral nutrition
- •Haemoglobin <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
- •Transcatheter aortic valve implantation
- •Active neoplasm
- •Patients who did not pause angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers or received non-steroidal anti-inflammatory drugs a minimum of 48 hours before hospital admission.
- •Patients who received intravenous radiocontrast agents within the 72 hours before hospital admission.
结局指标
主要结局
Occurrence of AKI after cardiac surgery
时间窗: 7 days
using full Kidney Disease: Improving Global Outcomes criteria
Long-term change in estimated GFR
时间窗: 3 months and 1 year after cardiac surgery
using CKD-Epidemiology Collaboration creatinine formula
次要结局
未报告次要终点
研究者
Faeq Husain
Senior Physician
University of Giessen