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临床试验/NCT00825318
NCT00825318已完成不适用

Pilot Trial To Study Blood Pressure, Weight and Hydration State in Patients Undergoing A Treatment Regimen of Daily Ultrafiltration and Twice-weekly Hemodialysis As Compared to Conventional Three Times Per Week Hemodialysis

Renal Research Institute3 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
3
主要终点
Mean Arterial Blood Pressure

研究概览

简要总结

In this study, the researchers want to find out how patients who have ultrafiltration (removal of excess fluid) 6 times a week and twice-weekly dialysis (removal of excess fluid and waste products) do in terms of their blood pressure and weight. The researchers believe that maintaining patients at their estimated target weight throughout the week using daily ultrafiltration will reduce their blood pressure to levels shown in other similar studies. Such a reduction in blood pressure may reduce the incidence of cerebral vascular disease, peripheral vascular disease, coronary artery disease, and congestive heart failure. The researchers also believe that patients' quality of life will improve while they are undergoing daily ultrafiltration.

Studies show that more frequent dialysis treatments result in fewer symptoms for patients. The patients feel better and avoid the weight gains and symptoms that patients have on three times a week dialysis. In addition, their blood lab results are better controlled, requiring less medication.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to 18 years and less than or equal to 80 years
  • Stable three treatments per week dialysis schedule for at least three months prior to beginning the study
  • Residual renal clearance <1.5ml/min per 35L of urea volume
  • Pre-dialysis serum sodium levels of greater than 136 mEq/L

排除标准

  • Non-compliance with hemodialysis treatments--defined as missing more than 1 treatment over the 3 month period prior to the study
  • Unable to verbally communicate in English or Spanish
  • Current requirement for hemodialysis more than three times per week due to medical comorbidity (including fourth session for ultrafiltration)
  • Currently on daily or nocturnal hemodialysis, or less than 3 months since discontinued such treatment
  • Expected geographic unavailability at dialysis center during any phase of the trial
  • Less than 3 months since the patient returned after acute rejection resulting in allograft failure
  • Currently in acute care or chronic care hospital
  • Pregnancy
  • Current involvement in any non-observational trial
  • Unable or unwilling to follow the study protocol for any reason (including mental incompetence)
  • Unable or unwilling to provide informed consent or sign IRB-approved consent form
  • Pace maker, implantable pump, artificial joint
  • Amputation of a limb

结局指标

主要结局

Mean Arterial Blood Pressure

时间窗: Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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