Efficacy and Safety of a Low-citrate-based Anticoagulation With Calcium-free Phosphate-containing Replacement Fluid Compared to Standard Citrate-based Anticoagulation Protocol in Patients Requiring Continuous Renal Replacement Therapy; a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 主要终点
- Circuit lifetime
研究概览
简要总结
In the present prospective multicenter RCT we will evaluate the effects on efficacy, acid-base status and serum phosphate levels of a new RCA protocol for Continuous Venovenous Hemodiafiltration (CVVHDF) using an 18 mmol/l citrate solution in combination with a calcium-free phosphate-containing solution, acting as dialysate and replacement fluid. The new protocol will be introduced with the following targets: a) to refine buffers balance of a previously adopted RCA protocol for Continuous Venovenous Hemofiltration (CVVH), based on a 18 mmol/l citrate solution (Regiocit) combined with calcium and phosphate-free dialysate fluid (PrismOcal B22) and a conventional phosphate-containing replacement fluid (Phoxilium) to prevent CRRT-related phosphate depletion
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
- Single (Participant)
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
- •Acute renal failure requiring CRRT
- •Suitability for regional anticoagulation of the CRRT circuit
- •Clinical equipoise regarding the method of circuit anticoagulation
- •Subject is affiliated with a social security system (if required by individual country regulations).
- •Subject meets national regulatory criteria for clinical trial participation.
- •Subject or subject's Legally Authorized Representative (LAR) has signed the study Informed Consent form
排除标准
- •Age less than 18 years
- •Expected stay in ICU less than 24 hours
- •Pregnant or breastfeeding
- •Suspected ischemic hepatitis or liver failure
- •Chronic kidney disease requiring dialysis prior to ICU admission
- •As applicable by French law, subject who is a protected individual such as an incompetent adult or incarcerated person
- •Metformin and acethaminophen intoxication
研究组 & 干预措施
Experimental Standard citrate protocol
CVVHDF will be performed using Regiocit solution in the predilution mode, Biphozyl in the dialysate and postdilution mode. CRRT will be started at a dose of 35 ml/kg/h.
干预措施: Biphozyl (dialysate and replacement) (Drug)
Conventionnal citrate protocol
CVVHDF will be performed using Regiocit solution in the predilution mode, Prismocal B22 (calcium and phosphate free) in the dialysate mode, and Phoxilium in the postdilution mode. CRRT will be started at a dose of 35 ml/kg/h.
干预措施: Prismocal B22 (dialysate) + phoxilium (replacement) (Drug)
结局指标
主要结局
Circuit lifetime
时间窗: First 3 days of continous renal replacempent therapy
Number of minutes lifespan circuit
次要结局
- Efficacy of the new RCA solution(first 3 days of CRRT)