跳至主要内容
临床试验/NCT03963960
NCT03963960终止不适用

Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis

Centre Hospitalier Departemental Vendee2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2021年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
13
试验地点
2
主要终点
Number of hypotension episodes

研究概览

简要总结

The objective of the EQUODIA study is to evaluate the hemodynamic stability of hemodialysis with low dialysate flow in patients requiring emergency hemodialysis in the context of acute kidney injury or unscheduled end-stage renal disease, not in intensive care, compared to conventional triweekly high-flow hemodialysis.

Short daily hemodialysis has excellent hemodynamic tolerance, which has already been confirmed by clinical experience. This modality, commonly used in the patient's home through new machines allowing a low dialysate flow purification technique, can prove to be an innovative, effective and safe alternative for patients admitted for hemodialysis in an unscheduled situation (acute kidney injury, unscheduled end-stage renal disease not followed).

Up to now, no studies have evaluated the use of short daily hemodialysis with low dialysate flow in patients with acute kidney injury or unscheduled end-stage renal disease, requiring the initiation of emergency extra-renal purification.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Male or Female 18 years of age or older
  • Patient requiring unscheduled hemodialysis for end-stage renal disease or acute kidney injury
  • Patient able to understand the protocol
  • Patient who has agreed to participate in the study and has given express oral consent
  • Patient affiliated to a social security system

排除标准

  • Patient with more than one dialysis session
  • Intensive care patient (need for vasoactive amine infusion, non-invasive ventilation, assisted ventilation)
  • Patient participating in interventional clinical research involving a drug/medical device
  • Patient under guardianship, curator, deprived of liberty
  • Pregnant or breastfeeding patient, or with the ability to procreate without effective contraception
  • Patient refusing to participate
  • Patient unable to understand the protocol and/or give express oral consent

结局指标

主要结局

Number of hypotension episodes

时间窗: During the first two weeks of dialysis

Decrease of ≥ 20 mmHg systolic blood pressure in regard to pre-dialysis value, associated with symptoms such as abdominal pain, yawn, nausea, vomiting, cramps, anxiety, dizziness, malaise and/or loss of consciousness

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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