跳至主要内容
临床试验/NCT01437761
NCT01437761终止不适用

Hemodialysis With the 2008 Sorbent System: A Pilot Evaluation of Different Treatment Prescriptions

Renal Research Institute1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
1
主要终点
Treatment Adequacy

研究概览

简要总结

This study will compare how well blood of renal failure patients is cleaned with the new 2008 Sorbent System using two different dialysate speeds.

详细描述

The "2008 Sorbent System" is a new type of hemodialysis machine that requires only about 2 gallons of dialysate for a treatment because it can turn used dialysate into fresh dialysate again by filtering it through a special cleaning cartridge (called a "sorbent"). This new machine is approved by the U.S. Food and Drug Administration to clean the blood of patients whose kidneys have failed.

This study will compare the degree of blood cleansing achieved with the new 2008 Sorbent System using two different speeds at which the dialysate runs through the dialysis machine. This will tell us if the faster speed really does provide better cleaning (and how much) with this new machine.

How well the blood of a patient is cleaned by this procedure is determined by several factors. For example, longer treatment times generally provide better blood cleansing. Higher speeds at which the cleaning fluid runs through the artificial kidney do, too.

Since the 2008 Sorbent System is a new machine (and in some ways different from standard hemodialysis machines), other aspects may be different, too, between the 2008 Sorbent System and regular hemodialysis machines. Specifically, this study looks at how well this new machine corrects the patients' acid-base status (a common requirement in these patients), what effect the treatment has on inflammation in the patients' blood, how the levels of important substances in the blood are influenced (acetate, sulfate, nitrate, carbon dioxide), and if cleaning fluid in the 2008 Sorbent System contains any substances that are not found in the cleaning fluid used by regular hemodialysis machines.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age </=18 years
  • end-stage renal disease (ESRD) patient on chronic high-flux hemodialysis for </= 6 months at time of enrollment
  • well-functioning fistula, graft or catheter as hemodialysis access, achieving blood flow rates of >/= 300 mL/min
  • ability to understand the English language

排除标准

  • Pre-dialysis serum blood urea nitrogen (BUN) concentration below 30 mg/dL in the last three months
  • Severe Coronary Heart Disease or Heart Failure (New York Heart Association class IV)
  • Active Infections
  • Hepatitis B
  • Any other active infection that has required antibiotic treatment in the preceding eight weeks
  • Pre-study lab values of any of the following (in the most recent routine lab work)
  • Sodium - Na+ > 150 mmol/L, Na+ < 132 mmol/L
  • Potassium - K+ > 6.5 mmol/L, K+ < 3.5 mmol/L
  • Total Calcium - Ca > 12 mg/dL (3 mmol/L), total Ca < 7.2 mg/dL (1.8 mmol/L)

结局指标

主要结局

Treatment Adequacy

时间窗: 4 weeks

spKt/V, eKt/V, and Std Weekly Kt/V (Kt/V = dialysis adequacy)

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 (1)

Loading locations...

相似试验