NCT00454974已完成1 期
Preliminary Study to Assess the Safety and Efficacy of a Wearable Artificial Kidney Device for the Treatment of Patients With Endstage Renal Failure
Royal Free Hampstead NHS Trust2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2007年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- urea, potassium, phosphate and B2M clearances
研究概览
简要总结
This is a pilot study of a wearable type of kidney dialysis machine to treat patients with chronic kidney disease.
详细描述
This is a pilot study to evaluate the clearances, tolerability and safety of a wearable artificial kidney device for treating patients with chronic kidney failure.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End stage renal failure
- •Regular haemodialysis
- •Cardiovascular stability
- •Stable vascular access
排除标准
- •Allergy to heparin or ethylene oxide
- •Recent cardiovascular or neurological event
- •Unable to provide informed consent
- •Age < 18
结局指标
主要结局
urea, potassium, phosphate and B2M clearances
safety - cardiovascular,no hemolysis, bleeding, infection
no ammonia generation from sorbents, control of acid base balance
次要结局
- fluid removal
- patient satisfaction questionnaire
- affect of treatment of cytokines
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Med-alert Bracelet in Chronic Kidney DiseaseChronic Kidney DiseaseNCT00883389University of Maryland, Baltimore26
已完成
不适用
Prehabilitation for Adults With End Stage Renal Disease on the Kidney Transplant WaitlistKidney Failure, ChronicNCT02895243Johns Hopkins Bloomberg School of Public Health18
已完成
不适用
DDEP for Lifestyle Modification in Chronic Kidney DiseaseChronic Kidney DiseasesNCT06226649National Cheng Kung University120
Unknown
不适用
Evaluating the Use of the Qidni/D Hemodialysis System by Subjects With End-Stage Renal DiseaseKidney Disease, End-StageNCT06086470Qidni Labs Inc.30
已完成
不适用
Dialysis Exercise With a Bed Compatible Leg TRAiningstoolChronic Kidney DiseasesHemodialysisNCT06045442University of Erlangen-Nürnberg Medical School32