Comparison of the Effectiveness of Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patients With Acute Renal Injury : a Monocentric Controled Randomized Non Inferiority Open Labeled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- urea reduction rate (URR)
研究概览
简要总结
In patients requiring renal replacement therapy (RRT) in the intensive care unit (ICU), continuous techniques are predominantly using due to better hemodynamic tolerance. The most employed techniques in ICU are continuous venovenous hemodiafiltration (CVVHDF) and continuous venovenous hemodialysis (CVVHD).
To our knowledge, there are no prospective studies comparing the efficiency of these two techniques with the same dose of dialysis (and the same filter).
In the CompEER study, we aim to compare the efficiency of CVVHD and CVVHDF on urea reduction rate in intensive care patients with acute kidney injury.
The research hypothesis is that CVVHD citrate technique is as effective as CVVHDF heparin technique for urea reduction and provides prolonged and stable clearance, facilitating antibiotic management during RRT.
详细描述
Acute Kidney Injury (AKI) is found in more than 50% of intensive care unit (ICU) patients, with 30% classified as AKI Network (AKIN) stage 3. Approximately 23% of AKI patients undergo RRT, predominantly utilizing continuous techniques due to better hemodynamic tolerance in unstable patients. Common continuous RRT techniques include continuous venovenous hemofiltration (CVVH), continuous venovenous hemodialysis (CVVHD), and continuous venovenous hemodiafiltration (CVVHDF).
The two most employed techniques in ICU are CVVHDF and CVVHD. However, the choice often depends on institutional practices rather than scientific evidence. Limited studies comparing these techniques at equivalent doses exist, and French recommendations allow intensivists discretion based on availability and team experience. A small, randomized study comparing different exchange rates found higher urea reduction in CVVHDF but lacked statistical significance. Current practices in ICU involve using CVVHDF with systemic anticoagulation or CVVHD with regional citrate anticoagulation based on practitioner preferences.
Despite potential benefits of CVVHD with citrate, such as extended filter lifespan and stable dialysis dose, the impact on concomitant treatments, especially antibiotics, needs consideration.
The study aims to demonstrate the non-inferiority of citrate-based continuous hemodialysis (CVVHD) compared to heparin-based continuous hemodiafiltration (CVVHDF) in terms of urea reduction rate at 24 hours in AKI patients requiring renal replacement therapy.
The hypothesis is that CVVHD citrate is as effective as CVVHDF heparin, providing prolonged and stable clearance, facilitating antibiotic management during RRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adult patients hospitalized in ICU
- •Undergo RRT session because of AKI stage 3
- •At least one among criteria: pH < 7,20 / Blood urea > 30mM / Fluid overload uncontrolled by with PaCO₂ < 35 mmHg or mixed acidosis with PaCO₂ < 50 mmHg.
- •Oliguria lasting 72 hours or longer
- •Patients undergoing their first session of extracorporeal blood purification, initiated less than 12 hours prior to randomization
- •Patient having given free and informed consent, and having signed the consent form or patient included in an emergency situation
- •Patient affiliated with Social Security.
排除标准
- •End-stage chronic kidney disease on dialysis
- •Intoxication with a dialyzable toxin (lithium
- •Criteria for emergency dialysis initiation: hyperkaliemia >6,5mM with electrocardiographic signs
- •Medical contraindication to regional citrate: severe liver failure
- •Medical contraindication to anticoagulation or heparin anticoagulation: heparin induced thrombopenia or uncontrolled bleeding
- •Pregnant women, parturient or breast-feeding patient
研究组 & 干预措施
CVVHD
Patient requiring renal remplacement therapy treated with by continuous venovenous hemodialysis (CVVHD) method.
干预措施: CVVHD Dialysis parameters (Other)
CVVHDF
Patient requiring renal remplacement therapy treated with by continuous venovenous hemodiafiltration (CVVHDF) method.
干预措施: CVVHDF Dialysis parameters (Other)
结局指标
主要结局
urea reduction rate (URR)
时间窗: 24 hours
The primary endpoint is the rate of urea reduction (TRU) at 24h as a percentage TRU H24 = (urea rate at H0 - urea rate at H24) / urea rate at H0 in each arm.
次要结局
- Urea clearance at H24(24 hours)
- Creatinine clearance at H24(24 hours)
- Urea clearance at H48(48 hours)
- Hypokalemia at Day 28(Day 28)
- Hypophosphatemia at Day 28(Day 28)
- ICU Mortality(End of ICU Stay)
- Mortality at Day 28(Day 28)
- Organ failure-free days at Day 28(Day 28)
- Hypomagnesemia at Day 28(Day 28)
- Hyperkalemia at Day 28(Day 28)
- Medical Cost(24 hours)