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临床试验/NCT02782234
NCT02782234Unknown不适用

Application of Contract Management Mode in Maintaining Body Fluid Balance of Peritoneal Dialysis Patients

The Second Affiliated Hospital of Harbin Medical University0 个研究点目标入组 72 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
72
主要终点
Change in Blood Pressure

研究概览

简要总结

Contract management is a new management mode.

To help patients achieve fluid balance through contract management, that is:

  1. edema, congestive heart failure and other similar symptoms begin to reduce to disappear;
  2. Blood pressure control in normal range, that is 90-140/60-90mmHg, or the target value prescribed by the doctors;
  3. Fluid intake and output keep in balance;
  4. No imbalance symptoms turn out, such as edema, congestive heart failure, etc.

详细描述

Contract management is a new management mode, it stipulate and constraint various relationship by various duties, institutions and regulations.

To help patients achieve fluid balance through contract management, that is:

  1. edema, congestive heart failure and other similar symptoms begin to reduce to disappear;
  2. Blood pressure control in normal range, that is 90-140/60-90mmHg, or the target value prescribed by the doctors;
  3. Fluid intake and output keep in balance;
  4. No imbalance symptoms turn out, such as edema, congestive heart failure, etc.

In addition to help keeping the fluid balance through contract balance, but also:

  1. Improve compliance;
  2. Improve the patients' cognition of fluid balance;
  3. Improve the ability of self-management of fluid balance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older or equal to 18 years, younger or equal to 65 years, CAPD duration over 6 months
  • Edema or congestive heart failure happen
  • Patients with poor control of blood pressure, that is less than 90/60mmHg,or over 140/90mmHg, or the Bp does not meet the value given by doctors
  • Patients with fluid imbalance of intake and output.

排除标准

  • Younger than 18, or older than 65, or CAPD period less than 6 months
  • The primary disease is high blood pressure, or edema due to low protein
  • Patients that lost control of daily life
  • Malignant tumor or pregnancy
  • Falling in Chronic infection or severe complication within 1 month, such as hepatic disease, hemorrhage of digestive tract, etc.
  • Patients with cognition impairment, conscious disorder, or mental disease.

结局指标

主要结局

Change in Blood Pressure

时间窗: two times a day, through study completion, an average of 6 months. changed from baseline

two times a day, blood pressure measure at a.m.6∶0 0~ 8∶0 0 ,p.m.15∶0 0~ 18∶0 0. The subjects for the first time measuring blood pressure for the baseline.

Change in weight

时间窗: once a day, through study completion, an average of 6 months. changed from baseline

The subjects for the first time measuring weight for the baseline measured in kg.

Volume of fluid intake and output keep in balance measured in ml.

时间窗: 24 hours

as the physiological parameter for this Outcome. Volume measurement unit should be used in pd subjects, the unit ml.

次要结局

未报告次要终点

研究者

发起方
The Second Affiliated Hospital of Harbin Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Li Liu

Supervisor nurse

The Second Affiliated Hospital of Harbin Medical University

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