Studio Cross-Over Controllato Randomizzato Sul Dispositivo ArTis Con Hemocontrol in Emodiafiltrazione - SOCRATHE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Sodium mass balance
研究概览
简要总结
The current study aims to assess the HemoControl prescription in On-Line Hemodiafiltration treatment.
详细描述
Hemodiafiltration (HDF) is a dialysis technique that allows the removal of high molecular weight toxic solutes exploiting the convective transport through the dialyzer membrane: at the same time, the HDF has a positive impact on the systemic hemodynamic, ameliorating in this way the tolerance of the treatment. Unfortunately, also the HDF therapy can be not well tolerated, introducing in the patients serious hypovolemia during the removal of the body water accumulated in the interdialytic period.
The HemoControl system, automatically controlling the relative blood volume change of the patient, avoids the onset of the hypovolemia. Today the HemoControl system can be used only during conventional hemodialysis treatments; the objective of this study is to combine the advantages of the intradialytic hemodynamic stabilization achievable by means of HemoControl with the inherent advantages, both of depurative and cardiovascular kind, typical of the Hemodiafiltration technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •A subject must meet ALL of the following inclusion criteria in order to participate in this study:
- •ESRD in chronic dialysis treatments for at least 3 months
- •Age ≥ 18 years
- •Body weight ≥ 40 kg
- •Blood flow rate ≥ 250 ml/min with a recirculation of the vascular access < 5%
- •Use of not fractioned heparin in continuous infusion as anticoagulant
- •Stable anticoagulation dosage over the last 6 treatments
- •Stable dialysis prescription (Qb, Qd, treatment time) over the last 6 treatments
- •Informed consent for participating to the study
- •Stable Haemoglobin concentration at beginning of the treatment lower than or equal to 14 g/dl.
排除标准
- •A subject shall NOT participate in the study if he/she meets ANY of the following criteria:
- •HIV positivity
- •Active Hepatitis A, B or C
- •Pregnancy
- •Participating in other clinical investigations during the course of this study
- •Failed to release consent
- •Known coagulation disorders (clotting problems)
- •Known bleeding risk
- •Clinical or laboratory diagnosis of acute infection
- •Recent (last 4 weeks) surgical intervention
- •Therapy prescribed is only HD, HF or isolated UF mode
- •Active phase cancer,
- •Active phase immune disease.
- •Serious hemostasis disorders.
结局指标
主要结局
Sodium mass balance
时间窗: during dialysis treatment within 18 weeks
* to determine whether the same HemoControl prescription is usable in On-Line Hemodiafiltration (HDF) and hemodialysis (HD) treatments and, if not, * to assess the existence of a proper HemoControl prescription in On-Line Hemodiafiltration (HDF) treatment.
次要结局
- blood pressure(Pre-dialytic within 18 weeks)
- thirst perception(during dialysis within 18 weeks)
- weight gain(between dialysis treatments within 18 weeks)