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临床试验/NCT00966615
NCT00966615已完成4 期

The Effect of Neutral Peritoneal Dialysis Solution With Minimal Glucose-Degradation-Product on the Fluid Status and Body Composition - A Randomized Control Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2010年9月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
68
试验地点
1
主要终点
arterial pulse wave velocity

研究概览

简要总结

Chronic utilization of bio-incompatible peritoneal dialysis (PD) solution has been implicated as a cause of progressive loss of peritoneal permeability and recurrent fluid overload in PD patients. Previous studies show that PD solution with neutral pH and low GDP resulted in a superior profile of PD effluent mesothelial cell marker and a lower degree of systemic inflammation as compared to conventional PD solution. The investigators propose a prospective randomized control study to compare the arterial stiffness, nutrition and body fluid status between PD patients treated with conventional solution and those with neutral pH low GDP solution. The investigators plan to study 100 new PD patients. They will be randomized to be treated with neutral pH low GDP solution or conventional solution. All patients will be followed for 52 weeks. In addition to routine clinical measurements, the investigators will measure their body water composition by bioimpedance spectroscopic method, arterial pulse wave velocity by pressure transduction method, as well as radiographic parameters of intravascular volume status, based on the routine chest radiograph. The study would help to define the clinical benefit of biocompatible PD solution.

详细描述

(see above)

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •new adult continuous ambulatory peritoneal dialysis (CAPD) patients, both diabetic and non-diabetic

排除标准

  • •unlikely to survive, planned to have elective living-related kidney transplant, or transfer to other renal center within 6 months

研究组 & 干预措施

Balance group

Experimental

peritoneal dialysis with neutral peritoneal dialysis solution with minimal glucose-degradation-product

干预措施: double-chamber bag Stay-Safe Balance system (Other)

Control group

Active Comparator

conventional PD solution

干预措施: glucose-based dialysis solution (Other)

结局指标

主要结局

arterial pulse wave velocity

时间窗: 52 weeks

body composition

时间窗: 52 weeks

次要结局

  • peritonitis-free survival, actuarial and technique survival(52 weeks)
  • nutritional and adequacy indices(52 weeks)
  • residual renal function(52 weeks)
  • peritoneal transport characteristics(52 weeks)
  • hospitalization(52 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheuk-Chun SZETO

Professor

Chinese University of Hong Kong

研究点 (1)

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