Remote Ischemic Preconditioning as a New Method of Nephroprotection in Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- incidence of acute kidney injury within 72 hours after cardiac surgery
研究概览
简要总结
Remote ischemic preconditioning (RIPC), elicited by brief episodes of ischemia and reperfusion in distant tissue, offers a protection against acute kidney injury (AKI) in patients after cardiac surgery. Investigators conducted a prospective, randomized, controlled clinical trial to assess whether RIPC reduces the incidence of AKI measured by standard way using serum creatinine concentration (SCr) and with use of serum level of neutrophil gelatinase-associated lipocalin (NGAL) as a new potential biomarker of a kidney injury. Moreover the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective, isolated, primary off-pump coronary artery bypass graft surgery (OPCAB).
详细描述
Cardiac surgery patients have a high risk of AKI. The development of AKI is associated with higher mortality and a higher risk for complications in patients undergoing cardiac surgery. However, there are no effective clinical strategies for preventing prevalence of AKI. RIPC as a simple, inexpensive way of protecting tissues against ischemic damage, may also reduce kidney injury. That makes RIPC under the area of interests of many researches which apply this method to prevent AKI. Investigators conducted a single-center, double-blind trial involving patients at high risk of postoperative AKI, in which want to check wether RIPC reduce the prevalence of AKI, according Kidney Disease: Improving Global Outcomes (KDIGO) definition, by increase in SCr. Furthermore researchers want to investigate a benefit from RIPC in reduction of level of SCr and higher glomerular filtration rate (GFR) 72 hours after off-pump coronary artery bypass as well as reduction of postoperative expression of NGAL an early biomarker of AKI.
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
- Single (Investigator)
盲法说明
Patients were randomly assigned in 1:1 ratio to either the RIPC group or the control group by means of a computerized randomization table.
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
- •Human patients with coronary artery disease.
排除标准
- •history of cardiac surgery,
- •acute myocardial infarction up to 7 days before surgery,
- •chronic kidney disease in 4th or 5th stadium (eGFR<30 ml/min/1,73m2),
- •peripheral vascular disease affecting upper limbs,
- •history of severe injuries and surgeries in 2 months before cardiac surgery,
- •history of cancer, acute inflammation during hospitalization,
- •chronic autoimmunology diseases,
- •dialysis patients.
结局指标
主要结局
incidence of acute kidney injury within 72 hours after cardiac surgery
时间窗: 72 hours after cardiac surgery
increase in serum creatinine level by more than 50% or more than 0.3mg/dL from baseline within 72 h after surgery
NGAL level
时间窗: 3 hours after cardiac surgery
increased NGAL level within 3 hours after cardiac surgery
次要结局
- occurrence of postoperative atrial fibrillation(through ICU stay completion, an average of 5 days)
- ventilation time(through ICU stay completion, an average of 5 days)
- length of hospitalization(through hospitalization completion, an average of 14 days)
- length of intensive care unit (ICU) stay(through ICU stay completion, an average of 5 days)
- time of renal replacement therapy(through ICU stay completion, an average of 5 days)
- death(from date of randomization until the date of death from any cause, assessed up to 2 years)
研究者
Karolina Stokfisz
M.D.
Medical University of Lodz