Nephrologic Intervention in Patients Waiting for Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 410
- 试验地点
- 2
- 主要终点
- Change in Acute kidney injury stage defined using KDIGO (Kidney Disease Improving Global Outcomes) criteria
研究概览
简要总结
Acute kidney injury (AKI) is a frequent complication after cardiac surgery. Its incidence ranges from 19 to 44% depending on the study and which definition is used: Acute Kidney Injury Network (AKIN) classification or RIFLE criteria (Risk, Injury, Failure, Loss, End-Stage Kidney Disease) based on serum creatinine and urine output.
AKI is associated with increased mortality, more complications, a longer stay in the intensive care unit and hospital, and increased health care costs. Moreover, the patients who require renal replacement therapy (RRT) have the highest mortality and complications1.The mortality risk in patients developing acute renal dysfunction after cardiac surgery increases by approximately 40%, while the overall mortality rate after cardiac surgery ranges between 2% and 8%.
There are some well-known risk factors associated with AKI, including baseline patient characteristics (age and comorbidities), need of perioperative blood transfusion or presence of previous chronic kidney disease. The main objective of this study is to evaluate if a nephrologist management and control of potential risk factors of renal disease can be used to prevent AKI, thereby minimizing the risk of need RRT, reducing costs and improving survival in this patients.
详细描述
Aim The aim of this study is to assess if a nephrology intervention before cardiac surgery can reduce the postoperative incidence of AKI (Acute Kidney Injury).
Methods Trial design and participants Recruitment: unicentric Ethics approval: Clinical Research Ethics Committee of Bellvitge will have approved the study before initiation. All patients will give written informed consent. Patients will be able to withdraw informed consent.
Duration of the study: 3 years recruitment, 1 year follow-up.
Randomization
Eligible patients will be randomly assigned by using sequentially numbered, opaque, sealed envelopes. Patients will be allocated to one of two groups using shuffled envelopes at the moment of the first visit of the cardiac surgeon. The two groups will be:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •age >18 years
- •patients undergoing scheduled cardiac surgery
- •Informed consent
排除标准
- •a requirement for RRT before surgery
- •current outpatient management by a nephrologist or estimated GFR < 45 mL/min/1.73m2 estimated by CKD-EPI equation)
- •participating in another clinical trial
结局指标
主要结局
Change in Acute kidney injury stage defined using KDIGO (Kidney Disease Improving Global Outcomes) criteria
时间窗: Day of surgery, 4 and 12 months
rise in serum creatinine ≥26.5 μmol/L in 48 h, or rise 1.5-1.9 times from baseline or Urine output of 0.5 mL/kg/h for 6-12 h
次要结局
- Hospitalization days and length of stay in ICU(1 month)
- number of participants with Need of Renal Replacement Therapy(1 month)
- number of participants with Metabolic complications(4 and 12 months)
- Estimated glomerular filtration rate(Each day of the hospitalization, 4 and 12 months)
- number of participants with Inflammation adverse events(through study completion, up to 1 year)
- number of participants with Anemia and need of blood transfusion(1, 4 and 12 months)
- Mortality(through study completion,up to 1 year)
- number of participants with Need of Use of inotropes after surgery(The day of surgery)
研究者
Nuria Montero
Dr.
Hospital Universitari de Bellvitge