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临床试验/NCT01241994
NCT01241994已完成不适用

Automatic Adaptive System Dialysis (AASD) for Dialysis Related Hypotension and Intolerance: a Prospective Long-term Multicenter Study

IRCCS Azienda Ospedaliero-Universitaria di Bologna2 个研究点 分布在 1 个国家开始时间: 2010年11月16日最近更新:
适应症

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

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

研究者

研究点 (2)

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