Automatic Adaptive System Dialysis (AASD) for Dialysis Related Hypotension and Intolerance: a Prospective Long-term Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- number of intradialytic hypotensive events
研究概览
简要总结
AASD is a new dialysis technique based on the use of a mathematical model of intradialytic solutes and fluid kinetic, for the automatic elaboration of dialysate sodium and ultrafiltration rate profile. The aim of dialysate sodium and ultrafiltration rate profile is to obtain the higher stabilization of intradialytic extra cellular compartment, in consideration of end session targets: body weight and final patient's natremia. In this multicenter prospective controlled randomized trial the primary end-point is the clinical efficiency validation of AASD on intradialytic hypotension but also on thirst, cramps, headache, nausea, vomiting, hypotensive events observed in basal treatment (HD or HDF).
研究设计
- 研究类型
- Interventional
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
- •Patients in HD/HDF (bicarbonate dialysis/hemodiafiltration) for at least 6 months
- •aged more than 18 years
- •on chronic thrice-weekly HD
- •symptomatic hypotension during at least 30% of dialysis sessions on basal treatment in the last month before admission or/and 1 hypotension /week
- •disequilibrium symptoms (cramps, headache, nausea, vomiting, hypotensive events) in at least 30% of dialysis sessions on basal treatment
- •dialysis session time: 4 hours (as much as possible)
- •Signed inform consent form
- •Patients having no vascular access related problems (bi-ponction, blood flow rate 300ml/min)
排除标准
- •Patients in a pregnant state
- •Patients whose life expectancy is less than study period
- •Patients with progressive acute pathology (neoplasia...)
- •Patients included in an other protocol
- •Psychiatric patients or patients unable to consent or unable to follow the study
结局指标
主要结局
number of intradialytic hypotensive events
次要结局
- percentage of dysequilibrium symptoms
