The Effect of Filter Lifespan in Continuous Renal Replacement Therapy on the Rate of New Infections in Critically Ill Patients: a Prospective, Multicenter, Observational Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 5
- 主要终点
- Number of new infections since start of dialysis
研究概览
简要总结
The only supportive therapy for patients with AKI is renal replacement therapy (RRT). In the ICU setting, continuous RRT (CRRT) is mostly favored. In a post-hoc analysis of the RICH trial (regional citrate versus systemic heparin anticoagulation for CRRT in critically ill patient with AKI), it was shown that the filter life span is associated with an increased rate of new infection and that the type of anticoagulants did not directly affect infection rate. The mechanisms of this infection rate is unknown.
详细描述
Approximately every second patient in the ICU suffers from acute kidney injury (AKI) which complicates the clinical course of these patients. Continuous renal replacement therapy (CRRT) has become the most widely used form of renal support in critically ill patients as it allows continuous, controlled removal of fluids and is hemodynamically better tolerated compared to intermittent dialysis. The requirement for intravascular access and artificial circuits may increase the risk of infection. However, there are no studies analyzing the incidence and characteristics of infections in critically ill patients with CRRT or the implications for outcome. Therefore, this observational trial investigates the factors that influences new onset infection in critically ill patients with CRRT.
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
- •Adult patients (age ≥18 years)
- •Critically ill patients with dialysis-dependent AKI
- •Continuous renal replacement therapy (CRRT)
- •Written informed consent
排除标准
- •Chronic kidney disease with estimated glomerular filtration rate (eGFR)<30ml/min/1.73m2
- •Chronic dialysis dependency
- •Kidney transplant
- •(Glomerulo-)nephritis, interstitial nephritis, vasculitis
- •Patients on immunosuppression
- •Patients with chronic inflammatory diseases (e.g. arthritis, HIV, chronic hepatitis)
- •Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
结局指标
主要结局
Number of new infections since start of dialysis
时间窗: From start of dialysis until day 28
次要结局
- Filter live span(From start of dialysis until day 28 or end of CRRT, whatever occurs first)
- Down-time of CRRT in hours(From start of dialysis until day 28 or end of CRRT, whatever occurs first)
- Number of new urinary tract infection(From start of dialysis until day 28)
- Number of bleeding complications(From start of dialysis until day 28)
- Recovery of kidney function(At day 90 after start of dialysis)
- Number of patients with need for kidney replacement therapy(At day 90 after start of dialysis)
- Number of new blood stream infections(From start of dialysis until day 28)
- Number of new catheter blood stream infection(From start of dialysis until day 28)
- Number of new other infections(From start of dialysis until day 28)
- Number of bacterial contamination of t he CRRT circuit proven by culture(From start of dialysis until day 28 or end of CRRT, whatever occurs first)
- Duration of mechanical ventilation in hours(From start of dialysis until day 28)
- Mortality(At day 90 after start of dialysis)
- Number of new pneumonia(From start of dialysis until day 28)
- Days on renal replacement therapy(From start of dialysis until day 28)
- Major adverse kidney events (MAKE)(At day 90 after start of dialysis)