Study of Cellulose Triacetate Dialyzer (Solacea™): in Vivo Behavior in Hemodiafiltration-online
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Biocompatibility of asymmetric cellulose triacetate (ATA™)
研究概览
简要总结
In post-dilution haemodiafiltration only synthetic membranes have been used to date.
The allergy problems described with these membranes require the development of other membranes capable of performing this treatment. We describe in vivo performance and behaviour of an asymmetric cellulose triacetate(ATA™) membrane, to identify its depurative effectiveness and ease of use in clinical practice, as well as evaluate its biocompatibility in a single haemodialysis session (acute biocompatibility) and after one month of treatment (chronic).
详细描述
An interventional study was performed in 3 hemodialysis hospital units (La Princesa University Hospital, Príncipe de Asturias University Hospital and Infanta Leonor University Hospital, Community of Madrid, Spain) in which the usual dialyzer that each patient had for OLHDF was replaced with the Solacea™ dialyzer keeping the rest of the parameters unchanged. The study (LIB 09/2015) was reviewed and approved by the CEIC of the Príncipe de Asturias University Hospital.
- Design of the study Each patient underwent 12 sessions of haemodialysis with the usual schedule and monitor: 5008 of Fresenius (n=14), AK200US (n=5) and Artis of Gambro (n=3) and DBB007 of Nikkiso (n=1) all suitable for OLHDF, although with different convective transport control systems. The nursing staff connected the automatic OLHDF system. In the case where the system was Ultracontrol® (Gambro monitors) if alarm of PTM> 300 mmHg or system pressure (PSist)> 700 mmHg appeared and were not solved, Ultracontrol® would be withdrawn and the pressure-control system would be used.
- Data to be collected:
- Demographic and dialysis data
- Demographic: sex, age, underlying disease, time in OLHDF, type of vascular access: fistula (AFV) and catheter (CT).
- Dialysis Data: Monitor, dialysis fluid composition, sodium conductivity and bicarbonate concentration, dialysis fluid flow (Qd, ml min), liquid temperature, heparin type and dosage.
- Each dialysis session: effective time (TE, min), blood flow (Qb, ml min), ultra-filtrated volume to achieve dry weight (UF, l/session), Vinf (l/session), infusion rate, (Qi, ml/min) Kt (l / session), maximum PTM and maximum Psist in Ultracontrol® (mmHg) and the technical complications, alarms and coagulation problems of the system that may appear.
The filtration fraction (FF) was calculated as the percentage of Qi relative to Qb. The convective volume (Vconv) was defined as the total ultra-filtrated volume, which is the sum of VI and UF.7 2. Analytical determinations
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Criteria:being over 18 years old, being treated with OLHDF for more than 4 weeks with 3 weekly sessions and sign an informed consent form.
排除标准
- •pregnancy and illness that would make the patient's death predictable in less than 4 weeks.
结局指标
主要结局
Biocompatibility of asymmetric cellulose triacetate (ATA™)
时间窗: One month
Studying its acute (measuring complement and leukocites) and chronic (measuring monocytes subpopulationsand interleukines)
Performance of asymmetric cellulose triacetate (ATA™)
时间窗: One month
Describing in vivo depurative efficacy of asymmetric cellulose triacetate (ATA™) measuring Kt, infusion volumen and clearance of RR of different molecules
Clinical behaviour of ATA
时间窗: One month
Studuying alarm or clínical problemas related with dialyzer
次要结局
未报告次要终点