Contribution of Body Composition Monitor (BCM) Among Patients Using Daily Home Dialysis With Low Dialysate Flow : French Study Cohort
试验速览
- 阶段
- 不适用
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- OH sector measurement by bio-impedancemetry.
研究概览
简要总结
The fluid overload measured by the Body Composition Monitor (BCM Fresenius Medical Care) is a new independent risk factor of mortality.
This risk has already been described in intermittent hemodialysis patients and peritoneal dialysis patients but never evaluated in Daily Home Dialysis with low dialysate flow.
The investigator propose a first study measuring the state of hydration by impedancemetry (BCM) in this population.
The aim of this work is to to analyze hydration status in a representative sample of prevalent Daily Home Dialysis with low-flow Dialysate patients.
Secondary objectives are to identify associations between hydration status and patient characteristics and treatment practice in order to find out which conditions should alert the clinician to potential fluid overload, to compare these results with the peritoneal dialysis population and in center hemodialysis population, to evaluate the correlation between impedancemetry and blood pressure in this population, to assess the nutritional status and evaluation of a new method of measurement of kt / V based on impedancemetry, without recourse to a blood test.
详细描述
Study objectives
This study is a cross sectional, observational trial in 11 centers in France. The primary objective is to analyze hydration status in a representative sample of prevalent Daily Home Dialysis with low-flow Dialysate patients.
Secondary objectives are to identify associations between hydration status and patient characteristics and treatment practice in order to find out which conditions should alert the clinician to potential fluid overload, to compare these results with the peritoneal dialysis population and in center hemodialysis population, to evaluate the correlation between impedancemetry and blood pressure in this population, to assess the nutritional status and evaluation of a new method of measurement of kt / V based on impedancemetry, without recourse to a blood test.
Centers
Participants in this study are: CHU de Caen, Tenon Hospital, CHG Saint-Lô, CHG Alençon, CHG Flers, CHG Lisieux, CHG Evreux, ANIDER Rouen, CHG Le Havre, A.U.B Rennes, A.D.P.C Marseille.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient with chronic end stage renal failure
- •Patient prevalent in home daily hemodialysis with low dialysate rate for more than 3 months.
- •Patient followed at the University Hospital of Caen, Tenon Hospital (Paris), CHG Saint-Lô, CHG Alençon, CHG Flers, CHG Lisieux, CHG Evreux, ANIDER Rouen, CH Le Havre, A.U.B Rennes, A.D.P.C. Marseille
排除标准
- •Reversindication to impedancemetry: patient with a pacemaker or an implantable defibrillator,
- •Population not validated for impedancemetry: pregnant or lactating woman, major amputation.
结局指标
主要结局
OH sector measurement by bio-impedancemetry.
时间窗: 5 minutes
Two electrodes will be glued to one wrist and two others to the ipsilateral ankle. The measurement is painless. Distribution of patients in 4 groups: Normohydrate group: OH between -1.1L and + 1.1L Hypovolemic group: OH \<-1.1L Hyperhydrate group: OH between + 1.1L and + 2.5L Heavy hyperhydrate group: OH\> + 2.5L
次要结局
- EPA scale(1 minutes)
- Mini Nutritional Assessment (MNA) score(5 minutes)
- Measuring blood pressure(10 minutes)