Randomized Blinded Controlled Pilot Study on Clinical Assessment of Continuous Hemodialysis With a High Molecular Flux Membrane
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- improvement in haemodynamic parameters
研究概览
简要总结
This is a monocentre randomized pilot study. All patients received two consecutive RRT: CVVHD with MCO filter (Ultraflux® EMiC®2) and post-Continuous Veno-Venous Hemodiafiltration (CVVHDF) with HFF(AV1000S®) in a controlled randomized (1:1) blinded manner. Crossover randomized to sequence (A+B or B+A) for 48 h total without washout.
详细描述
This is a monocentre randomized pilot study. All patients received CVVHD with MCO filter (Ultraflux® EMiC®2) and post-Continuous Veno-Venous Hemodiafiltration (CVVHDF) with HFF(AV1000S®) in a controlled randomized (1:1) blinded manner. Crossover randomized to sequence (A+B or B+A) for 48 h total without washout.
The efficiency of the filters for small and middle molecules was compared in septic shock patients with AKI stage 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Blinding procedure was limited to the doctors who collected the data and the external statistician who performed the analysis
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
- •Age > 18 years;
- •septic shock according to ACCP/SCCM criteria
- •AKI KDIGO stage 3
- •clinical decision to begin citrate based-RRT for at least 48 hours
- •Hb >= 9 g/dL
- •Obtain the informed consent
排除标准
- •Pre-existing chronic renal insufficiency
- •Weight > 125 kg Life expectancy <24 hr
- •Declared do Not Resuscitate or Comfort Measures
- •Platelets < 20 [10^3/ul] or active bleeding
- •Pregnancy
- •Contraindication to citrate
结局指标
主要结局
improvement in haemodynamic parameters
时间窗: 48 hours
measurements of the hemodynamic parameters: mean arterial pressure (MAP, mmHg)
次要结局
- Efficiency for middle molecules(48 hours)
- removal of antibiotics(48 hours)
- clerance of cytokine(48 hours)
- Efficiency for small molecules(48 hours)
研究者
Fiorenza Ferrari
Senior Consultant at intensive Care Unit of Hospital San Matteo, Pavoa, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia