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临床试验/NCT03578510
NCT03578510已完成不适用

Is the Lower Incidence of Intradialytic Hypotension During Hemocontrol Dialysis in Comparison With Standard Hemodialysis Attributable to Enhanced to Higher Plasma Vasopressin Levels or to Enhanced Sympathetic Activity and/or to Less Nitric Oxide Production

University Medical Center Groningen2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2012年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Change in plasma vasopressin levels

研究概览

简要总结

Intradialytic hypotension (IDH) is a frequent and serious complication that may occur during hemodialysis treatment. The investigators and others have shown that the Hemocontrol biofeedback system is associated with improved hemodynamic stability. Hemocontrol is a technique that guides the patients' blood volume along a pre-set trajectory by continuously adjusting the ultrafiltration rate and dialysate conductivity. In a recent pilotstudy, the investigators found significantly higher plasma vasopressin levels during the first hour of dialysis with Hemocontrol in comparison with standard hemodialysis. Increased vasopressin levels may contribute to intradialytic hemodynamic stability during hemodialysis by enhanced vasoconstriction. These results, however, did not prove directly that the improved hemodynamic stability with Hemocontrol is indeed caused by higher initial plasma vasopressin levels. Alternative explanations might be that 1) the higher initial plasma sodium levels with Hemocontrol dialysis enhance activity of the sympathetic nervous system directly, causing vasoconstriction and thereby improved hemodynamic stability and/or 2) that the higher initial plasma levels of sodium in Hemocontrol inhibit the release of nitric oxide by the vascular endothelium. Another goal of this study is to investigate whether vasopressin is removed with hemodialysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • A thrice-weekly 4 hours hemodialysis schedule
  • Dialysis on an arteriovenous fistula
  • A usual interdialytic weight gain of ≥2.0 kg

排除标准

  • Age<18 years
  • Dialysis duration of <4 or >4 hours
  • Dialysis frequency of <3 or >3 times a week
  • Dialysis on a central venous catheter
  • A usual interdialytic weight gain <2 kg

结局指标

主要结局

Change in plasma vasopressin levels

时间窗: Before, after 30, 60, 120 and 180 minutes and after dialysis blood is withdrawn from the dialysis line to determine plasma levels of vasopressin.

Plasma levels of the antidiuretic hormone, i.e. vasopressin

次要结局

  • Change in relative blood volume in %(Before, after 30, 60, 120 and 180 minutes and after dialysis)
  • Change in plasma sodium levels in mmol/L(Before, after 30, 60, 120 and 180 minutes and after dialysis)
  • Change in systolic and diastolic blood pressure in mmHg(Before, after 30, 60, 120 and 180 minutes and after dialysis)
  • Change in heart rate in beats per minute(Before, after 30, 60, 120 and 180 minutes and after dialysis)

研究者

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

dr. C.F.M. Franssen

Principal Investigator

University Medical Center Groningen

研究点 (2)

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