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临床试验/NCT03322410
NCT03322410Unknown不适用

Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability

CHU de Reims1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
CHU de Reims
入组人数
40
试验地点
1
主要终点
Hydratation status

研究概览

简要总结

Bioimpedance is recently known to be a reliable, reproducible and validated technic allowing determination of hydratation status in patients with chronic kidney disease treated with peritoneal dialysis (PD). Overhydratation attested by bioimpedance is strongly associated with cardio-vascular morbidity and mortality in patients with PD. Overhydratation might concern more than half of patients at PD initiation, though the underlying mechanism remains unknown.

High peritoneal permeability (HPP) might concern about a third of patients starting a PD, although only a few datas are published on this condition. HPP at initiation of PD is associated with a decrease in both technical and patient survival and might be responsible of ultrafiltration failure. The underlying mechanisms of HPP at initiation of PD also remains unknown.

To our knowledge, the correlation between hydratation status and peritoneal permeability at initiation of peritoneal dialysis remains unknown. Moreover, there is no datas concerning the cinetic evolution of peritoneal permeability; demographic or biologic factors associated with HPP in days and months following PD start.

The aim of the present study is to correlate hydratation status (attested by bioimpedance) and peritoneal permeability at early start of peritoneal dialysis. Thus, we investigated early cinetic of peritoneal permeability at different time point during the first year of peritoneal dialysis and we analyzed the demographical and biological factors associated with HPP and overhydratation during this period.

This study is a prospective, multicentric cohort study. Fourty patients recruited in a two years' period in five centers of nephrology will be included. Hydratation status will be determined with Fluid Overload measurement by bioimpedance technic thanks to BCM system (Fresenius Medical Care®). Peritoneal permeability will be determined by modified Peritoneal Equilibration Test with complete drainage at sixty minutes. Datas will prospectively be collected, including: weight, blood pressure, diuretic posology, diuresis, PD modality, dialysate prescribed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Patients

Experimental

干预措施: modified Peritoneal Equilibration test (Biological)

结局指标

主要结局

Hydratation status

时间窗: Day 7

Fluid overload (FO) measured with BMC bioimpedance system (Fresenius medical care®) * FO \< 10th percentile = extracellular dehydration * 10th percentile \< FO \< 90th percentile = extracellular normohydration * FO \> 90th percentile = extracellular hyperhydration

次要结局

  • Peritoneal permeability(Day 365)
  • Hydratation status(Day 365)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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