Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Post-dialysis body weight
研究概览
简要总结
The goal of this prospective, randomized, controlled, cross-over, multicentric study is to demonstrate the safety of bioLogic Fusion in patients on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes. The main question it aims to answer is:
• Which is the number and percentage of individual sessions with reached prescribed post-dialysis body weight in the prescribed treatment time in each single session in hypotensive-prone patients on high-flux haemodialysis or hemodiafiltration within each patient with treatments performed with DialogiQ with (treatment A) or without (treatment B) the bioLogic Fusion option activated? Participants will in addition to their routine dialysis treatment undergo 2 physical examinations and regularly answer questionnaires.
A crossover design is used to compare treatments with or without the BioLogic Fusion function activated.
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
- •Male or female subjects ≥18 years of age
- •Chronic bicarbonate standard high-flux haemodialysis or hemodiafiltration for at least 3 months
- •Dialysis frequency 3 x per week
- •Dialysis duration per session ≥ 4h
- •Patient on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes
- •No residual renal function (definition: ≤100 ml urine/day) - changed to "No to minimal residual renal function (definition: ≤ 300 ml/day)" with Amendment 1 (CIP version 6)
- •Stable dry body weight for at least 4 weeks
- •Subjects who are willing to give a voluntary consent to participate in the study
排除标准
- •Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
- •Vascular access insufficiency (mean blood flow <200ml/min)
- •Patients treated with dialysis profiles: sodium profile, Ultrafiltration (UF) profile, and temperature profile - changed to: " Patients treated with dialysis profiles during the 9 prescreening visits: sodium profile, UF profile, and temperature profile. However, patients on sodium, ultrafiltration or temperature profiling expected to reduce intradialytic hypotensive episodes can be evaluated for enrollment when their frequency of sessions complicated by hypotension demonstrate the lack of efficacy of the applied profiles" with Amendment 1 (CIP version 6)
- •Use of the BioLogic fusion function during the last 9 dialysis sessions recorded at the site (retrospective screening period)
- •Pregnant or nursing women. Women of childbearing potential must agree to avoid pregnancy during the study period
- •Factors which may interfere with full participation in the trial
- •Any contra-indication to haemodialysis treatment per se, as described in the Instructions for Use (IFU)
- •Any serious medical condition or disability, which in the opinion of the investigator limits the life expectancy and would preclude completion of the study
结局指标
主要结局
Post-dialysis body weight
时间窗: 12 weeks
percentage of sessions with reached prescribed post-dialysis body weight
次要结局
未报告次要终点