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临床试验/NCT02557347
NCT02557347已完成4 期

The Efficacy of Managing Fluid Overload in Peritoneal Dialysis Patient by a Structured Nurse-lead Intervention Protocol

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
102
试验地点
1
主要终点
degree of overhydration

研究概览

简要总结

The objective of this study is to determine the effectiveness of treating peritoneal dialysis (PD) patients with fluid overload by a structured nurse-lead intervention protocol. We plan to recruit 100 PD patients with fluid overload. These patients will be assessed and managed by a renal nurse specialist in the ambulatory renal center according to a standardized protocol. The improvement in the degree of overhydration will be determined by bioimpedance spectroscopy 4 and 12 weeks after treatment.

详细描述

Fluid overload is a common problem in peritoneal dialysis (PD) patients and it is associated with left ventricular hypertrophy and other adverse cardiac consequences. Fluid management is therefore an important aspect in the management of dialysis patient. In Hong Kong, PD patients with common medical problems related to dialysis are assessed and managed in the renal nurse clinic by pre-approved intervention protocols. Although it is the general impression that management of PD patients with fluid overload by a nurse-lead intervention protocol is robust and could reduce the work load of medical staff, the efficacy of this approach remains undetermined. The objective of this study is to determine the effectiveness of treating PD patients with fluid overload by a structured nurse-lead intervention protocol. We plan to recruit 100 PD patients with fluid overload, which is defined as overhydration (OH) ≥ 2 litres as measured by bioimpedance spectroscopy. These patients will be assessed and managed by a renal nurse specialist in the ambulatory renal center according to a standardized protocol previously approved by the Hospital Authority. The improvement in the degree of overhydration will be determined by bioimpedance spectroscopy 4 and 12 weeks after treatment. Change in body weight, blood pressure, degree of oedema, as well as the knowledge on salt and fluid restriction will also be assessed.

研究设计

研究类型
Interventional
分配方式
Na
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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • PD patients with overhydration (OH) ≥ 2 litres as measured by bioimpedance spectroscopy

排除标准

  • overt pulmonary edema and required urgent medical care
  • cognitive impairment or problem of communication
  • unlikely to survive for more than three months
  • mechanical problems of the dialysis catheter
  • active peritonitis or peritoneal failure

结局指标

主要结局

degree of overhydration

时间窗: 12 weeks

measured by bioimpedance spectroscopy

次要结局

  • blood pressure(12 weeks)
  • patient knowledge(12 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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