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
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
- 否
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时间窗: Before, after 30, 60, 120 and 180 minutes and after dialysis blood is withdrawn from the dialysis line to determine plasma levels of vasopressin.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
dr. C.F.M. Franssen
Principal Investigator
University Medical Center Groningen
