Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients.
试验速览
- 阶段
- 4 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting.
研究概览
简要总结
The purpose of this study is to compare the feasibility, safety and efficacy of hemodialysis with unfractionated heparin compared to hemodialysis with Citrasate in Critically Ill Patients.
详细描述
Objective : To compare the feasibility, safety and efficacy of Sustained Low Efficiency Daily Hemodialysis (SLEDD) using regional anticoagulation with Citrasate® compared to systemic anticoagulation with unfractionated heparin in critically ill patients.
Design : Prospective, randomized, single-center clinical trial Setting : mixed medical-surgical 45 bed ICU in a tertiary university hospital Patients : 250 patients with Acute Kidney Injury (AKI) stage III needing renal replacement therapy Interventions : Patients are randomized to receive SLEDD using standard dialysate and systemic anticoagulation with UF versus SLEDD using Citrasate®-dialysate with no additional UF.
Measurements and main results :
Primary end point :
- The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting.
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
- •Need for hemodialysis in the ICU for at least one treatment
- •No prior hemodialysis treatment in the ICU except continuous renal replacement therapy
排除标准
- •Need for systemic anticoagulation with unfractionated or fractionated heparin, oral anticoagulants or intravenous anti-aggregants for other reasons
- •Need for continued thrombolysis therapy within the 6 hours before inclusion
- •Need for continued treatment with activated protein C (drotrecogin alfa) within the 12 hours before inclusion
- •Need for continued treatment with intravenous anti-aggregants (abciximab, eptifabide) within 12 hours before inclusion
- •Liver failure (acute and acute-on-chronic)
- •Confirmed or suspected Heparin Induced Thrombocytopenia (HIT)
- •Heparin allergies
- •Severe uncorrected hypocalcemia (ionized calcium < 0,8 mmol/l)
- •Refusal of informed consent
研究组 & 干预措施
Standard Anticoagulation
Hemodialysis is performed using standard anticoagulation using unfractionated heparin if no contra-indications for the use of heparin exist. If contra-indications for heparin exist a heparin coated hemofilter (Evodial) will be used. The use of unfractionated heparin or no heparin (with coated hemofilter) is a decision to be taken before every hemodialysis.
干预措施: Unfractionated heparin (Drug)
Citrasate
Hemodialysis is performed with Citrasate
干预措施: Citrasate (Drug)
结局指标
主要结局
The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting.
时间窗: 6 hours after starting dialysis
次要结局
- The incidence of technique failure defined as the number of patients who develop a contra-indication for the allocated anticoagulation regimen during the study period(during whole wtudy)
- The incidence of bleeding episodes. A bleeding episode is defined according to the WHO bleeding criteria(during the whole study period)
- The transfusion requirements defined as the total of units blood products administrated during the ICU stay and per dialysis treatment(during the whole study period)
- The incidence of metabolic derangements during the study period(during the whole study period)
- Dialysis efficiency expressed as Kt/V and URR(6 hours after starting dialysis)